FDA & LASIK

The LASIK industry & the FDA have conspired since LASIK’s inception to purposely withhold information vital to the public in making a truly informed LASIK decision. With Lasikdecision.com, The hope is to show you what the industry and FDA would not and did not even think of doing until LASIK casualties started speaking out, and yet, they still did NOTHING.

Video Testimony on LASIK, Depression, and Suicide From the April 25th, 2008 Special Hearing of the FDA’s Ophthalmic Devices Panel

“The FDA’s capacity to oversee the refractive surgery industry is in my opinion no different than the doctors who have tarnished it. The FDA has been ineffective in overseeing investigational studies, ineffective in enforcing the policies mandated for the industry, and ineffective in providing thus far the protection that many of us here today should have had.” Dom Morgan (Speaker #6) – April 25th, 2008, FDA Ophthalmic Panel Meeting.

On April 25th, 2008, the FDA’s Ophthalmic Panel held an open public meeting to address ‘Quality of Life’ issues after Refractive Surgery. Among the presenters were Gerry Dorrian, whose son took his own life in 2007 as a result of his complications. David Shell help up charts depicting his distorted vision.

The ‘positive side’ was shown as well. The military spoke stating this was one of the best procedures available for those in the field. Doctors brought in patients potraying lasik as a miracle.

The panel was made aware that refractive surgery had a complication rate of about 5%. Think about it: If 1 million people had the procedure done, then that means 50,000 (5%) were damaged. Majority rules though, so 50,000 doesn’t mean anything to the FDA. What about 5 million? That would make 250,000 people with complications! When I hear that the FDA is influenced by financial interest, you get no argument, especially since I’ve seen how they work!!!

As the FDA wants information on quality of life, I say give it to them. Anyone who’s had a complication from refractive surgery send them your story. Let them know what your life is like now. And if you’re sending it to them, copy, paste, and send a copy to me because they simply cannot be trusted!

FDA Continues Inadequate Protection

WHAT HAPPENS WHEN THE FDA HEARS THE TRUTH? ABSOLUTELY NOTHING!

Michael Patterson
[Redacted]

June 1, 2009

Daniel Schultz, M.D.
Director, Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Dear Dr. Schultz:

Please respond to this letter on or before June 15, 2009 so I can address this issue in any government briefings scheduled for June. In my opinion, the fact that the FDA is out of compliance is very important to the decision-making process of the patient. There is a vast difference between “safe, approved and monitored” versus “approved but unmonitored, unreported, and unknown”.

On July 22, 2008, you wrote a letter to me regarding LASIK issues and safety concerns. You stated that presentations given by injured LASIK patients at the April 2008, Ophthalmic Devices Panel meeting made you “keenly aware” of problems I and others experienced.

In that letter, you stated that the FDA would be implementing changes “as soon as possible”.  I recognize the updates to the FDA LASIK website and other activities including Timothy Ulatowski’s 5/22/2009 letter to Eye Care Professionals concerning LASIK advertising. In the thirteen months since the hearing, however, I have not seen any substantive changes and the inhumane breaches of the FDA regulations continue status quo. This is unacceptable.

Please address the issues below and why another FDA petition has Not been answered more than one year after it was properly filed with the FDA (see attached Exhibit 3, FDA-2008-P-0319-0001, and http://www.lasikcomplications.com/Citizen-Petition-to-Ban-Lasik.pdf). Is it true that none of the FDA clinical trials used by the FDA to approve the lasers meet the FDA’s own criteria for approval? Is it true that even after the “healing period” of six months that the percent of patients reporting complications are:
17.5% halos?
19.7% glare?
19.3% night driving problems?
21% dry eyes?
5% severe dry eyes (e.g., Cataract & Refractive Surgery today June 2008)?

As you are undoubtedly aware, the FDA continues to endorse (and fund) a plan to conduct a prospective quality of life after LASIK study in collaboration with biased LASIK surgeons who have clear financial conflicts of interest and who are under pressure from members of their professional societies to improve their LASIK profits. Yet none of the representatives of the LASIK study have contacted a single LASIK victim or Doctor representative who spoke at the FDA panel meeting in April 2008.

In fact, when I recently contacted the NIH to participate in this FDA funded LASIK study, I was told there are no studies regarding LASIK at all (but there is one on Dry Eye). Where did the funds that were spent on this LASIK study go? I ask the FDA to clarify where the millions of dollars supposedly spent on this study to date have gone and which LASIK Doctors received the funds and how the taxpayers benefitted (if at all).

A recent letter (see attached Exhibit 1) seeking a moratorium on LASIK devices to members of the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations and other congressmen addressed concerns about the FDA “putting the fox in charge of the hen house” in the proposed study.  A group of LASIK victims (PhDs, MDs, etc) has offered to conduct a study for $50,000 to $100,000 total via a nonprofit organization and only asks the government to help obtain access to the patients (as required for any study).

In your letter, you also agreed with my concern about under-reporting of adverse events by LASIK ambulatory surgical facilities (ASF), and stated that you were considering ways to address this important issue. You stated that FDA “has inspected three LASIK user facilities” since 2000. That is an appalling number out of the 1,000 plus ASFs and I believe an insult to the reputation and integrity of the FDA. You could have easily visited or directed other credentialed FDA personnel to visit nearby LASIK ASFs (in DC or elsewhere) to determine whether there was compliance with the MDR regulations. How many more facilities have been inspected after your letter was written? What is the current number of LASIK user facilities that have been inspected? Are any new inspections scheduled? Until the FDA discharges responsibility under current law, no new legislation is even necessary. Congress would be wise to give the new Commissioner time to get the Agency to perform as Congress and the public have already authorized before wasting time on new initiatives.
In addition to the MDR and other regulations for instance, the Safe Medical Devices Act of 1990 provides FDA regulatory authority. The Conference report to accompany H.R. 3095, SAFE MEDICAL DEVICES ACT OF 1990, is Report 101-959. It is 30 pages in length and describes all legislative changes including User Reports and Civil Penalties that the FDA can apply administratively without DOJ participation.

I also must insist that something be done about the evidence the FDA has that over 20% of LASIK surgeons admitted reusing Microkeratome blades on multiple patients and many have admitted reuse of these SUDS without any sterilization or reprocessing at all. I believe knowingly and intentionally Not protecting the public from known violations of Federal laws and regulations (e.g., reuse of adulterated FDA SUDS on multiple patients without reprocessing) may constitute reckless endangerment (from a negligent injury) and/or meet other criminal standards within both State and Federal jurisdictions.

Device Reuse

Device reprocessors of single use disposable devices (SUDS) are subject to the same requirements as original equipment manufacturers. SUD reprocessors, like original manufacturers, could meet their requirements in premarket applications by obtaining reference rights to information in the possession of other manufacturers.
Enforce premarket approval regulations for hospitals and third party SUD reprocessors for Class III devices;

Enforce premarket notification submission requirements for Class III and Class II single use devices; and,

Inspect 100 hospitals annually to evaluate their compliance with premarket clearance requirements and the requirements of the Quality System regulation. In FY 2003, inspections of hospitals reprocessing Class I devices will be formal Good Manufacturing Practices inspections, which are the same inspections performed on hospitals reprocessing higher risk Class II and III devices.

See the FDA’s database for information about microkeratome blade regulations and reprocessing (or lack thereof),

I believe the FDA has failed to address the important public health concern of under-reporting of LASIK adverse events and wasted taxpayer funds on issues that are designed to benefit the industry rather than the public. Earlier this week, yet another citizen petition was filed with the FDA which calls for inspections of LASIK facilities for compliance with medical device reporting (MDR) regulations, and sanctions on facilities that are not in compliance (see attached Exhibit 2). I anticipate that members of Congress along with the press and many injured LASIK patients will be watching FDA’s response to the petition.

I am planning to participate in a Congressional briefing in June in part regarding the following 3 Points of Discussion of what the FDA/CDRH has FAILED to do so since 1998:

  1. Provide adequate patient informed consent including the risks and warnings (see the FDA labeling). For instance, THE FLAP CREATED BY LASIK NEVER HEALS, LEAVING THE PATIENT WITH (2) EYES THAT ARE OPEN TO A LIFETIME OF INFECTION: The FLAP created from LASIK does NOT heal like a normal scar on the hand, but rather is open to infection for the remainder of one’s life, open to dislodgement, and the LASIK centers are NOT describing this properly to the public. If patients were told the truth, they would know LASIK devices are Not FDA approved for retreatment (deceptively called enhancements). Clinical trial investigators and ASFs also lie and mislead about the true LASIK failure (retreatment) rates. Call 10 LASIK Centers and ask them and record their responses today, so you understand how they are deceptively marketing LASIK to lure anyone willing to fork over $s.

Studies show up to 20% of patients receive LASIK retreatments (without informed consent that the FDA has Not approved any devices to be use for retreatments; http://optics.org/cws/article/research/17441). For example, see

ages 40+ has 14% (higher) Retreatment Rate http://www.revophth.com/index.asp?page=1_342.htm

2,485 eyes or 1,306 patients study: showed an average of 10.5% Retreatment/Failure Rate, 85% of Retreatment(s) took place within 1st year
http://www.ophsource.org/periodicals/ophtha/article/S0161-6420(02)01981-4/abstract

This study shows 10.5% versus industry showing 5%-28%.
http://www.vision-institute.com/director/LASIK%20retreatment.pdf

Shows 10% failure rate.
http://optics.org/cws/article/research/17441

Shows 10.6% retreatment rate. 379 eyes, 256 patients http://voi.opt.uh.edu/VOI/WavefrontCongress/2006/presentations/FriJan27PosterSessionC7F6/31FRY.pdf

Each FDA-approved laser has an approval order with the Patient Information Booklet (PIB) mandate. The Patient Information Booklet is the device equilvalent to the package insert supplied with a prescription drug. Don’t overlook the significance and importance of this document. Use this document in your client’s case in the same way you would use the package insert for a prescription drug. “In advance of surgery, all prospective patients must receive the Patient Information Booklet (as described in your final submission to this PMA) from their treatment providers.”

Click the following link: FDA approved lasers for LASIK. Then click “list of FDA-approved lasers for LASIK”. Patient Information Booklets are located under the column “Instructions”. So why don’t most LASIK ASFs provide patients the Patient Information Booklet as required by the FDA regulations? Who are the “distributors” and “users” who are required to provide the labeling in the PIBs? The Doctors are the Only “users” licensed to use the microkeratomes (that are required for LASIK- see the Bausch & Lomb Microkeratome cover sheet for the physician only licensing information), but the FDA denies authority or jurisdiction over the distributors (ASFs), the users (the Doctors), or the labeling (the authority to make PIBs are provided to patients). If the Doctors are the ONLY licensed users and the FDA will Not insist they comply with Federal laws or regulations, then the FDA is Not in compliance with Federal law. Why does the FDA deny its regulatory authority over and over?

The FDA asserts the authority during the approval process.
For example see this letter regarding the VISX laser,

“We note that you have provided the requested Patient Information Booklet, which you have committed to make available to users and patients upon request.”

“Re: P930016/S12
VISX STAR S2 and S3 Excimer Laser Systems”
(formerly at http://www.fda.gov/cdrh/pdf/P930016S012a.pdf, no longer on the FDA website).

At the same time, the FDA denies any authority over distributors, users or the labeling.

“FDA’s Authority

FDA regulates the sale of medical devices in the U.S. and monitors the safety of all regulated medical devices.

In the U.S., FDA regulates the sale of medical devices such as the lasers used for LASIK. Before a medical device can be legally sold in the U.S., the person or company that wants to sell the device must seek approval from the FDA. To gain approval, they must present evidence that the device is reasonably safe and effective for a particular use.

The FDA does not have the authority to:

  • Regulate a doctor’s practice. In other words, FDA does not tell doctors what to do when running their business or what they can or cannot tell their patients.
    Set the amount a doctor can charge for LASIK eye surgery.
  • “Insist” the patient information booklet from the laser manufacturer be provided to the potential patient.
  • Make recommendations for individual doctors, clinics, or eye centers. FDA does not maintain nor have access to any such list of doctors performing LASIK eye surgery.
  • Conduct or provide a rating system on any medical device it regulates.

http://www.fda.gov/MedicalDevices

LASIK ASF’s/DOCTORS ARE NOT REPORTING “BAD LASIK PATIENT OUTCOMES,” THEREFORE THE PUBLIC ISN’T MADE AWARE THAT THERE ARE as many as 700,000 LASIK adverse events, not the 142 that the FDA stated on 4/24/09. Only a year later that number has jumped to over 1,300! Did you know that the FDA/CDRH has not required LASIK centers to file ADVERSE EVENTS? Most LASIK ASFs  have ZERO reports. Why did the FDA state there were only 142 complaints knowing this is false?

Based on objective evidence and congruent with the interest of the public health, the FDA should modify its website to inform the public that
1) LASIK ASFs are not being inspected, and
2) The FDA ignores the Federal Law that requires their inspection.

This notification needs to be prominently displayed at the top of the FDA LASIK information site. Why? Because the public has every reason to believe that the FDA is enforcing all applicable laws with regard to LASIK approvals and ASFs. With industry studies showing a 5% dissatisfaction rate and a 5% rate of one complication- severe dry eye, about 400,000 people are permanently injured by LASIK without even adequate palliative care (e.g., severe dry eye). If the FDA/CDRH reports a 95.4% Success Rate, that means there is a 4.6% Failure Rate! That means that there are hundreds of thousands of EYES that are considered FAILURES, never to be fixed again. Yet, the number of adverse events reported by the FDA was only about 140 before the 2008 Hearing of the Ophthalmic Devices panel. As such, the FDA has conclusive statistical evidence that ASF are not reporting adverse events, and in spite of this evidence, the FDA continues to taken no reasonable action regarding LASIK ASFs. In the case of financial fraud, the public relies on the SEC to investigate. Similarly, the public assumes that the FDA is investigating and evaluating safety of the devices used for LASIK and falsely thinks that LASIK is much safer than it really is because the FDA is Not actually doing what the FDA is supposed to do.

Last year the LASIK industry reported that only 140 reports of LASIK dissatisfaction had been filed with the FDA from 1998 to 2006. What is the current total number of LASIK device adverse events, including blade and laser keratomes, and how many negative comments have been received through the FDA LASIK webpage online feedback form?

Re-Treatment Rates for LASIK surgeries are NOT being investigated even though they should have been since 1998. The following documentary further proves (news worth, Fox News 2000) that Alcon had a slew of complaints from both patients and from doctors using the Ladarvision Laser. The complaints from doctors stated that the re-treatment rates were well beyond the FDA allowable 10%, and more like 20-60%. Yet none of the lasers were seized by the FDA/CDRH and the LASIK ASF’s did not comply by submitting the mandatory “Adverse Event/Complication” into the Medwatch/Maude internal FDA/CDRH “complaint reporting system.” No disciplinary measures were taken on any of the doctors either. This is very disturbing!

See how the FDA has over 1,300 LASIK Maude/Medwatch Complaints, not the 142 they released to the press last year? Enter dates from 01/01/1997 to 05/27/2009 using bottom right Product Code Box: LZS. (Formerly at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm)

THE MICROKERATOME BLADE AND SUCTION RING NEVER WENT THROUGH CLINICAL STUDIES AND IS BEING REUSED OVER AND OVER FURTHER HURTING ALL LASIK PATIENTS. The Microkeratomes (and more recently intralase lasers) were approved with a 510(k), but should have gone through a compound PMA application along with the lasers (requiring clinical trials because the flap is REQUIRED by definition for LASIK). Using a blade or the laser to cut a flap is plagued with problems. “The Microkeratome, a cutting instrument, is attached to the suction ring. Your doctor will use the blade of the Microkeratome to cut a flap in your cornea. Microkeratome blades are meant to be used only once and then thrown out. The Microkeratome and the suction ring are then removed.” Formerly at http://www.fda.gov/cdrh/lasik/expect.htm, no longer on the FDA’s website.

In my opinion, your personal performance is below acceptable standards. I look forward to your response.

Sincerely,

Michael Patterson
[Redacted]
npatter9@hotmail.com
6/1/2009

cc: Dr. Margaret A. Hamburg, FDA Commissioner
Representative Bart Stupak, Chairman, Subcommittee on Oversight & Investigations
Representative Henry Waxman, Chairman, House Energy and Commerce Committee
Senator Edward M. Kennedy, Chairman, Senate HELP Committee
Representative John Lewis, Georgia’s 5th District
Senator Saxby Chambliss, Georgia
Senator Johnny Isakson, Georgia
And others

EXHIBITS

EXHIBIT 1
Scott Tolchin
Founder, LASIK Surgery Watch Cause on Facebook
[Redacted]
Merrick, NY 11566


May 8, 2009

The Honorable Henry Waxman
Chairman
Committee on Energy and Commerce
2125 Rayburn House Office Building
Washington, DC 20515-6115

Dear Chairman Waxman:

My name is Scott Tolchin and I am the founder of the LASIK Surgery Watch Cause (LSWC) on Facebook. LSWC is a community of individuals that include patients damaged by LASIK surgery. The mission of the LASIK Surgery Watch Cause is to advocate on behalf of patients who have suffered adverse effects of LASIK surgery so that they can be counted, heard, and understood.

I am seeking an immediate moratorium on the use of excimer lasers for LASIK surgery as there has never been a clinical trial to support the safety guideline of less than 1.0% occurrence of adverse events required by the Food and Drug Administration (FDA) for approval.

Approximately 20% of patients in FDA clinical trials for LASIK reported complications (glare, halos, night driving problems, and dry eyes) at six months after surgery which were worse than before surgery, much worse than before surgery, moderately severe or severe. These complications were deceptively reported in clinical trials as “symptoms” rather than “adverse events” in order to satisfy safety guidelines. In 2008, the FDA reclassified these complications as reportable adverse events; however the agency allowed these devices to remain on the market for use in LASIK surgery.

Additional bases for a moratorium on LASIK devices include:

  • The FDA has been negligent in its oversight of LASIK ambulatory surgical facilities (ASF).  Part 803 of 21 CFR establishes reporting requirements for users of medical devices. Specifically, all LASIK device user facilities must submit FDA MedWatch reports of individual adverse events; establish and maintain medical device reporting (MDR) event files; develop, maintain, and implement written MDR procedures; and submit annual reports to the FDA. It is clear that users of LASIK devices have systemically failed to comply with MDR reporting requirements, which contributed to the FDA’s failure to monitor safety of LASIK devices post-market. This situation must be immediately rectified in order for the FDA to fulfill its post-market surveillance obligation.

  • In May, 2008 a citizen petition was filed with the FDA to ban LASIK due to substantial deception in the labeling and an unreasonable and substantial risk of injury. The CDRH has failed to respond to the petitioner within the 180 deadline established by 21CFR Sec. 10.30. The petition references data from FDA LASIK clinical trials, which establish the failure of LASIK lasers to meet the FDA’s safety requirements for approval. It appears that the FDA was derelict in its approval of LASIK devices, putting the interests of the ophthalmic industry ahead of its duty to protect the public health. The petition can be viewed at www.Regulations.gov, Docket ID FDA-2008-P-0319.

  • Transcripts of Ophthalmic Devices Advisory Panel meetings indicate that the FDA knew, or should have known, of serious problems with the LASIK procedure. Warning letters dating back to at least 1999 were issued by the FDA to LASIK clinical trial sponsors indicating deviations and deficiencies in the sponsors’ responsibilities to ensure that the studies were conducted in accordance with applicable FDA regulations.

  • FDA clinical trial study design for LASIK lacked sufficient duration of follow-up to detect late onset complications, such as corneal ectasia, a serious sight-threatening complication of LASIK that may occur years after the procedure. The small patient population and short-term follow-up did not allow for thorough examination of adverse events and long-term consequences of LASIK.

  • According to the American Academy of Ophthalmology (AAO), dry eye is the most frequent complication of LASIK; however, assessment for dry eye in LASIK clinical trials were purely subjective – there was no objective dry eye testing. Corneal nerve damage resulting from LASIK surgery leads to loss of corneal sensation, which invalidates subjective patient questionnaires in detection of post-LASIK dry eyes. Microscopic examination of post-LASIK corneas reveal reduced nerve density three years after surgery. The true rate of clinical dry eye after LASIK is likely much greater than reported in clinical trials.

  • The importance of pupil size in LASIK screening and surgical planning has been systemically ignored by LASIK clinical trial sponsors and investigators and dismissed by the FDA. Objective tests demonstrate that visual aberrations increase with increasing pupil size after LASIK. Failure of the FDA to place pupil-size restrictions in the device labeling led to improper treatment resulting in visual impairment of many patients.

  • The latest technology in LASIK surgery flap creation, femtosecond ophthalmic lasers, received FDA approval under a 510(K) application, bypassing the rigors and scrutiny of clinical trials. Numerous reports of complications associated with this device are found in peer-reviewed literature and in the FDA MedWatch database.

  • Since the media coverage of the April 25, 2008 FDA hearing on LASIK, adverse effect reports have surged! According to the FDA there were only 140 reports of adverse effects due to LASIK filed between 1998 and 2006. In 2008 alone, over 500 LASIK adverse event reports were filed. As most LASIK patients are unaware that the MedWatch reporting system even exists, and since the filing process is a visual process that may be inaccessible to many injured LASIK patients, it stands to reason that only a small fraction of adverse events are actually being reported.

  • In response to LASIK complaints and allegations of corruption surrounding the approval of LASIK devices, the FDA held a public meeting in April, 2008 to consider patients’ experiences with LASIK. The FDA announced that further study of LASIK dissatisfaction was needed and reported that it had formed an unprecedented partnership with LASIK professional groups to conduct a prospective LASIK study to begin in 2009. The proposed study amounts to putting the fox in charge of the hen house. Surgeons selected to lead the study include those with direct ties to LASIK device manufactures – a clear conflict of interest.

Congress and the American people should be made aware that there are universal adverse effects of LASIK, even in the absence of any immediate clinically relevant complications:

  • LASIK weakens the cornea, which may lead to late onset corneal failure.

  • The LASIK flap never completely heals and may be accidentally dislodged indefinitely.

  • LASIK patients are at life-long increased risk of corneal infections.

  • LASIK causes dry eye, which may be permanent.

  • LASIK complicates future cataract surgery.

  • LASIK invalidates intraocular pressure measurement, which is critical in the diagnosis of glaucoma.

  • Excimer laser ablation causes persistent keratocyte (corneal cell) death.

  • LASIK can lead to significantly reduced quality of vision, sometimes occurring years after the procedure.

At the present time, there is no technology that will restore a patient’s post-LASIK vision to the same quality experienced before undergoing LASIK surgery. Post-LASIK patients who are no longer able to work leads to additional costs to the US Treasury in the form of disability payments and a loss of revenues from formerly tax-paying individuals.

I believe the FDA Center for Devices and Radiologic Health (CDRH) and Office of Device Evaluation (ODE) has not maintained the distance from the LASIK devices industry required for impartiality. This has resulted in the FDA’s failure to uncover problems, apparent to others, with LASIK surgery.

The FDA should never have approved the use of excimer lasers for an elective eye surgery that was known to be harmful to patients. Congress must correct this error by instructing the FDA to fulfill its regulatory obligation to protect the American public from unsafe medical devices by withdrawing the approval of excimer lasers for LASIK.

Source material for the information discussed above can be provided upon request.

I look forward to a reply at your earliest convenience.

Sincerely,

Scott A. Tolchin
Founder, LASIK Surgery Watch Cause on Facebook
http://apps.facebook.com/causes/227958
[Redacted]


EXHIBIT 2

May 25, 2009

Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Dr. Margaret A. Hamburg
Commissioner of U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dr. Joshua M. Sharfstein
Principal Deputy Commissioner
Acting Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Daniel Schultz, M.D.
Director, Center for Devices and Radiologic Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

CITIZEN PETITION

The undersigned submits this petition under section 519 of the Federal Food Drug & Cosmetic Act (21 USC 360i), or any other statutory provision for which authority has been delegated to the Commissioner of Food and Drugs to request the Commissioner enforce compliance with medical device reporting (MDR) regulations by LASIK device user facilities and ASFs – Ambulatory Surgical Facilities (hereinafter referred to as “LASIK clinics”).

ACTION REQUESTED

The petitioner requests the Commissioner of Food and Drugs inspect LASIK clinics to ensure compliance with 21 CFR 803, Subpart C User Facility Reporting Requirements. Part 803 requires medical device user facilities to (1) establish written MDR procedures, (2) report adverse events to the manufacturer or to the FDA, and (3) submit annual reports to the FDA.

Further, the petitioner requests the Commissioner of Food and Drugs impose sanctions on non-compliant LASIK clinics as authorized under 21 USC 331 – 337. The regulation authorizes sanctions ranging from warning letters to injunction proceedings, civil penalties, and criminal penalties.

STATEMENT OF GROUNDS

In 1998, the FDA approved the first excimer laser for LASIK. Since then, approximately 8 million United States citizens have undergone the surgery.

It is now well-documented that problems after LASIK, such as night vision difficulties and dry eyes, occur frequently after LASIK.1 A meta-analysis of Summaries of Safety and Effectiveness for the twelve lasers approved for LASIK from 1998 through 2004 found that six months after LASIK, 17.5% of patients report halos, 19.7% report glare, 19.3% report night-driving problems and 21% report dry eyes which are worse than before surgery, much worse than before surgery, moderately severe or severe.2

Other complications of LASIK, such as irregular-thickness flaps, partial or incomplete flaps, buttonholed flaps, free caps (the flap is cut completely off), flap striae (wrinkles), decentered flaps, flap dislocation, infection, inflammation, haze, epithelial ingrowth, vitreoretinal complications, optic neuropathy, induced cataract, and corneal ectasia occur infrequently but may lead to irreversible vision loss. Complications may emerge weeks, months, or years after seemingly successful LASIK, which contributes to underreporting.

Long-term consequences of LASIK include problems with future cataract surgery, risk of undiagnosed glaucoma due to inaccurate intraocular pressure measurements, permanent biomechanical weakening of the cornea with associated risk of late-onset keratectasia (corneal failure), life-long increased risk of corneal infection due to a permanent portal in the corneal periphery for microorganisms to penetrate, persistent loss of keratocytes (corneal cells), reduced corneal nerve density, reduced visual quality, and non-healing of the LASIK flap (exhibit 1) with associated risk of late flap dislocation. These issues affect virtually 100% of LASIK patients.

The FDA requires that all prospective LASIK patients receive the Patient Information Booklet (device labeling) from their surgeon prior to surgery. Device labeling is intended to inform patients of contraindications and risks. LASIK surgeons commonly fail to provide the device labeling to patients, which denies patients access to information that could affect their decision to have the surgery.

Microkeratome blades which are used to cut the LASIK flap are cleared by the FDA for single-use, although surgeons routinely reuse the blade on the 2nd eye of the same patient. Reuse of blades on multiple patients has also been reported, which may expose patients to infectious contaminants. It is reported in the medical literature that quality of the flap-cut is reduced with reuse of blades. This exposes patients to an increased risk of complications in the second eye. Furthermore, tissue remnants left on the blade from the first eye may be dragged into the interface of the second eye, leaving debris trapped in the interface.

Over the past several years, patients who suffered serious complications, visual impairment, or chronic dry eyes after LASIK petitioned the FDA to ban LASIK or otherwise restrict the devices to provide greater protection to the public from improper use of LASIK devices. The most recent petition (located at http://www.regulations.gov, Docket ID FDA-2008-P-0319) was received by the FDA in May, 2008. No response has been issued as required by law, and no action has been taken by the FDA to provide better protection for the public.

In 2007, reports of LASIK-related suicides began circulating in the mass media.3 In February 2008, preliminary findings of an Emory Eye Center study of suicides among organ donors were reported in the media. These findings suggested a four-fold increased suicide rate among cornea donors who had had LASIK compared to cornea donors who had not had LASIK.4 These media reports were vigorously disputed by LASIK surgeons and LASIK industry consultants who openly denied any connection between a bad outcome from LASIK and diminished quality of life, depression, and suicide.5

On April 7, 2008, the American Society of Cataract and Refractive Surgery (ASCRS), a LASIK professional group, issued a press release6 announcing collaboration with the Agency to study post-LASIK quality of life and stated that only “140 comments relating to LASIK dissatisfaction” had been reported to the FDA in the past decade. This number, in contrast to the reported incidence of complications in FDA clinical trials, is a clear indication that LASIK clinics are not reporting LASIK adverse events as required by law. ASCRS speaks on behalf of the FDA in the press release stating, “The FDA reaffirms that LASIK is both safe and effective.” Injured LASIK patients would like to know the name of the FDA source for that statement. Earlier statements by Dr. Daniel Schultz, Director of the Center for Devices and Radiological Health (CDRH) reported in Reuters7 on March 17, 2008, seem to contradict ASCRS.

In March 2008, the FDA announced a special hearing of the Ophthalmic Devices Panel to be held on April 25, 2008 to address patient experiences with LASIK. Injured LASIK patients who spoke during the open public hearing had harsh criticism of the FDA’s unprecedented partnership with LASIK professional groups to study LASIK dissatisfaction.8 Injured LASIK patients believe that LASIK surgeons are biased and lack objectivity, and that the proposed study amounts to the FDA putting the fox in charge of guarding the hen house.
At the hearing, injured LASIK patients and family members of LASIK patients testified to the devastating psychological impact of post-LASIK dry eyes and night vision disturbances, including depression, suicidal thoughts, and actual suicides.9 Several speakers called for a moratorium on LASIK.10

An FDA Patient Representative brought several serious concerns surrounding LASIK to the attention of the FDA at the April 25, 2008 advisory panel meeting. Her testimony is published on the FDA website at http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4353t1-04.pdf beginning on page 315.

As media reports of the FDA hearing circulated, self-reporting of LASIK adverse events by patients to the FDA surged to over 500 in one year. Undoubtedly, patients were previously unaware of the FDA’s voluntary MedWatch program for reporting problems after LASIK. A disturbing trend can be seen in the patient reports – poor night vision, halos, starbursts, debilitating dry eyes, diminished quality of life, and denial by the LASIK surgeon.

In September 2008, the FDA updated its LASIK webpage to clearly define halos, glare, night vision problems and dry eye as adverse events which should be reported to the FDA.

In April 2009, LASIK surgeons led by Kerry Solomon, M.D. published results of a “world literature review” on LASIK satisfaction,11 which combined data from 19 peer-reviewed studies of 2,199 patients. The articles report that 95.4% of LASIK patients are satisfied with their surgical outcome. The authors state, “Although this database also includes information on visual outcomes, night vision symptoms, and dry eyes, for the purpose of this paper, the analysis of the database focuses specifically on patient satisfaction and quality of life”. Incidence of night vision disturbances and dry eyes reported by patients in the 19 studies was known by Solomon’s group, but not published. Injured LASIK patients who believe the literature review was a deceptive marketing ploy located several of the 19 studies and found the incidence of dry eyes and night vision disturbances in the 20 – 30 percent range.

Injured LASIK patients allege that the LASIK industry has engaged in a cover-up of the frequency and life-altering nature of LASIK complications, such as night vision disturbances and chronic dry eyes, and have consistently ignored MDR reporting requirements. Based on the number of LASIK MedWatch reports which are self-reported by patients, there is compelling reason to believe that most LASIK device user facilities have never filed a single MedWatch report.

The petitioner has no knowledge of data or information which are unfavorable to the petition.

ENVIRONMENTAL IMPACT STATEMENT

This petition qualifies for categorical exclusion under 21 CFR 25.30(a) from the requirement of an environmental impact assessment.

CERTIFICATION

The undersigned certifies that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.

___________________________
(Signature)

Scott A. Tolchin
[Redacted]

  1. Sugar A, Rapuano CJ, Culbertson WW, Huang D, Varley GA, Agapitos PJ, de Luise VP, Koch DD. Laser in situ keratomileusis for myopia and astigmatism: safety and efficacy: a report by the American Academy of Ophthalmology. Ophthalmology. 2002 Jan;109(1):175-87.

  2. Bailey MD, Zadnik K. Outcomes of LASIK for myopia with FDA-approved lasers. Cornea. 2007 Apr;26(3):246-54.

  3. Puglionesi, L (2007, July 6). “Haverford man found dead at old hospital site.” Accessed 5/21/2009 from Delaware County Daily Times online at http://www.delcotimes.com/articles/2007/07/06/; “Suicide Series Part 1: Mid-Life Suicides” (2008, March). Accessed 5/22/2009 from WXOW ABC 19 online at http://www.wxow.com/Global/story.asp?s=8571827; “Brentwood Officer Found Dead In Apparent Suicide”. (2008, March 17). Accessed 5/22/2009 from NewsChannel5.com online at http://www.newschannel5.com/Global/story.asp?S=8029702 (LASIK blamed in suicide note presented at April 25, 2008 FDA panel meeting located at http://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4353oph1-07%20TODD%20KROUNER.pdf, slides 6 – 8)

  4. Vollmer, S. (2008, February 3) Some link depression, failed LASIK. Retrieved 5/21/2009 from http://www.newsobserver.com/150/story/920341.html

  5. Lindstrom, Richard. (2008, March 12) Letter to the News & Observer: http://www.newsobserver.com/opinion/letters/story/996053.html; Morse M.D., Jennifer (2008, April 25) FDA Special Hearing on Post-LASIK Quality of Life: http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4353t1-02.pdf; Schallhorn, Steven C. (2008, February 3) Some link depression, failed LASIK: http://www.newsobserver.com/150/story/920341.html

  6. “ASCRS to participate in and co-fund study on post-lasik quality of life with US Food and Drug Administration” (2008, April 7). Accessed 5/22/2009 at http://www.ascrs.org/press_releases/ASCRS-TO

  7. Heavey, S. “FDA panel to review laser eye surgery” (2008, March 17). Reuters. Accessed 5/22/2009 at http://www.reuters.com/article/

  8. See 4/25/2008 testimony of Matt Kotsovolos, Dr. Lauranell Burch, Dom Morgan, Dr. Michael Patterson, David Shell, and Dr. Michael Mullery on the FDA website at http://www.fda.gov/ohrms/dockets, and http://www.fda.gov/ohrms/dockets/

  9. See 4/25/2008 testimony of Beth Kotsovolos, Gerard Dorrian, Dr. Michael Mullery, Dr. Roger Davis, Dr. Edward Boshnick, and Todd Krouner on the FDA website at http://www.fda.gov/ohrms/dockets/, and http://www.fda.gov/ohrms/dockets/

  10. See 4/25/2008 testimony of Dr. Michael Patterson, Matt Kotsovolos, Dr. Lauranell Burch, Dr. Michael Mullery, and Dr. Roger Davis on the FDA website at http://www.fda.gov/ohrms/dockets/, and http://www.fda.gov/ohrms/dockets/

  11. Solomon KD, Fernández de Castro LE, Sandoval HP, Biber JM, Groat B, Neff KD, Ying MS, French JW, Donnenfeld ED, Lindstrom RL; Joint LASIK Study Task Force. LASIK world literature review: quality of life and patient satisfaction. Ophthalmology. 2009 Apr;116(4):691-701.

[CITIZEN PETITION Exh]

“Your corneal flap will never adhere to the surface of the eye with quite the same strength it did prior to the surgery, so there is a rare but possible risk of the flap becoming displaced with sufficient force.” Source: October, 2008 publication of the American Academy of Ophthalmology (AAO), International Society of Refractive Surgery (ISRS), and Opthalmic Mutual Insurance Company (OMIC) titled “Is LASIK For Me? A Patient’s Guide to Refractive Surgery” located online at http://www.geteyesmart.org/correction/upload/LASIK_guide.pdf

“The corneal flap can be easily displaced following trauma many months after LASIK.” Source: Ramírez M, Quiroz-Mercado H, Hernandez-Quintela E, Naranjo-Tackman R. Traumatic flap dislocation 4 years after LASIK due to air bag injury. J Refract Surg. 2007 Sep;23(7):729-30.

“The LASIK flap once cut may contribute little to the mechanical stability of the cornea and probably never completely adheres to the underlying stromal bed, with late traumatic flap displacement being reported as an infrequent complication.” Source: O’Brart DP, Mellington F, Jones S, Marshall J. Laser epithelial keratomileusis for the correction of hyperopia using a 7.0-mm optical zone with the Schwind ESIRIS laser. J Refract Surg. 2007 Apr;23(4):343-54.

“Our report, as well as the related literature, indicates that the healing of the flap is incomplete even 6 years after LASIK surgery.” Source: Landau D, Levy J, Solomon A, Lifshitz T, Orucov F, Strassman E, Frucht-Pery J. Traumatic corneal flap dislocation one to six years after LASIK in nine eyes with a favorable outcome. J Refract Surg. 2006 Nov;22(9):884-9.

“Although ocular trauma with corneal laceration can occur, we report that the lamellar flap is still susceptible to ocular trauma 7 years after LASIK. Informed consent should include discussion of long-term flap complications and patients should be advised to protect their eyes after LASIK, especially during high risk activities.” Source: Jin GJ, Merkley KH. Laceration and partial dislocation of LASIK flaps 7 and 4 years postoperatively with 20/20 visual acuity after repair. J Refract Surg. 2006 Nov;22(9):904-5.

“The fact that this potential plane can be disrupted many years after LASIK (7 years after the initial surgery in patient 1) indicates that corneal integrity is compromised by the surgical procedure and takes a long time, if ever, to restore.” Source: Cheng AC, Rao SK, Leung GY, Young AL, Lam DS. Late Traumatic Flap Dislocations After LASIK. J Refract Surg Vol 22, May 2006

“Another aspect of LASIK surgery is that during this procedure, a corneal flap is made, which will create lifelong lamellar corneal potential space.” Source: Galal A, Artola A, Belda J, Rodriguez-Prats J, Claramonte P, Sánchez A, Ruiz-Moreno O, Merayo J, Alió J. Interface corneal edema secondary to steroid-induced elevation of intraocular pressure simulating diffuse lamellar keratitis. J Refract Surg. 2006 May;22(5):441-7.

“However, one aspect still in discussion is the wound-healing process in the created interface that leads to an easily removable flap even years after treatment.” Source: Priglinger SG, May CA, Alge CS, Wolf A, Neubauer AS, Haritoglou C, Kampik A, Welge-Lussen U. Immunohistochemical Findings After LASIK Confirm In Vitro LASIK Model. Cornea, Volume 25(3), April 2006, pp 331-335

“Corneal stromal LASIK wounds were found to heal weaker than normal because these structures were not regenerated during the healing response. Moreover, the central and paracentral stromal LASIK wounds were found to heal by producing a hypocellular primitive stromal scar that is very weak in tensile strength, averaging 2.4% of normal, and displays no evidence of remodeling over time in specimens out to 6.5 years after surgery.” Source: Schmack I, Dawson DG, McCarey BE, Waring GO 3rd, Grossniklaus HE, Edelhauser HF. Cohesive tensile strength of human LASIK wounds with histologic, ultrastructural, and clinical correlations. J Refract Surg. 2005 Sep-Oct;21(5):433-45.
“However, this case illustrates that even 4 years following the procedure, the lamellar flap remains an inherently weakened area of the eye, susceptible to traumatic disruption.” Source: Nilforoushan MR, Speaker MG, Latkany R. Traumatic flap dislocation 4 years after laser in situ keratomileusis. J Cataract Refract Surg. 2005 Aug;31(8):1664-5.

Microkeratome Blades, And the FDA, They ALLOWED IT!

How would you feel if you received an infectious disease or permanent injury caused by

…the reuse of an FDA “regulated” medical device AFTER the CDC and the FDA knew about an unsafe risk and did nothing?

Many Microkeratome components used for LASIK are licensed, “regulated” and approved by the FDA solely as single-use, disposable medical devices, but the FDA states the FDA has No jurisdiction to enforce Federal laws regarding these FDA approved medical devices.

Hundreds of LASIK Doctors have admitted reusing these single use blades, but none have lost their medical licenses and only a few have even been placed on temporary probation (to my knowledge).

Read More

The FDA does Not regulate the practice of medicine, but the FDA does regulate all users and practitioners of these devices. 

Not everything that a medical Doctor does is considered the practice of medicine.  Being a licensed medical Doctor does Not allow a person to break Federal or State laws.

An off-label use of a device explicitly for the potential benefit of a patient (where the benefit clearly outweighs the risk) would be considered a legitimate practice of medicine.  However, when there is no patient benefit and/or the risk outweighs any benefit, then Not following the FDA labeling does Not constitute the practice of medicine By definition.  Part of the definition of the practice of medicine is to put the patients’ best interests ahead of those of the Doctor.

Why isn’t any practitioner or user of these FDA “regulated” (Class I) medical devices (whether or Not he/she happens to be a Doctor) who uses them in an unnecessarily risky way or who does Not provide informed patient consent under the FDA’s regulatory authority and jurisdiction?

Read More

The House of representatives has investigated the FDA regarding allowing these harmful practices

…(as reported in the Washington Post).  “If there is the remotest possibility that a catheter might be used twice, that you could potentially harm a patient, you should not use it,” he said. “It’s common sense.”

“The Washington Post examined thousands of pages of documents, including FDA records, court filings and internal company reports, and was able to document dozens of cases of patient injuries and device malfunctions after single-use devices were reused over the past decade”

Read Their Article

Microkeratome blades get duller every time they are reused which causes irregular flaps made in the cornea, less smooth flaps, epithelial ingrowth, keratitis, and other serious problems.

Read More

The FDA hasn’t even responded to a request for humanitarian aid or compassionate use of a medical device. 

They don’t do anything about Doctors Not providing the Patient Handbooks, violating the labeling (including false advertisements), or Not informing patients they are getting an “off-label” treatment, but when the FDA was asked to simply put in writing that the manufacturer and a Doctor can do a treatment zone .5mm wider than the current 6.5mm maximum approved by the FDA (to come closer to matching an actual pupil size), the FDA would Not put it in writing.  Is that humanitarian or compassionate?

Read More

“IF Doctors who do “second opinions” after LASIK (this is a big business due to all the people with problems) are used to seeing good results from LASIK, then why aren’t the Damages from reusing microkeratome blades obvious to them? 

As odd as it sounds, many patients have told me their Doctors acted as if they did Not believe what they were telling them about their eyes and vision.  My own statements about my vision and eye pain, etc. do Not appear in many of my medical records, and some Doctors have one diagnosis but Not others (in some cases I initially found out Only by getting copies of my medical records because some of the Doctors did Not tell me they had put these diagnoses in my records).  One Doctor who was on the FDA’s Ophthalmic devices panel said the objective evidence (without reviewing my artemis or confocal exams) was Not consistent with what I said about my vision.  I was shocked when he said “I know many patients who would be happy with your vision”.  I’m sure that blind people would be happy with my vision, but how does that help with my terrible vision and eye problems that bother me all the time?”

Read More

“LaserVue reused microkeratome blades among patients rather than sterilizing or replacing them.  Former patients may have been exposed to infectious diseases such as HIV or Hepatitis.”

Read More

“I must protest – there could never be legitimate reasons for placing patients at incredible risk of HIV, viral hepatitis, or Mad Cow disease

 – all which can potentially be transmitted via the use of unsterilized sharp instruments. There is absolutely no excuse for this.  It goes against every medical standard and as well goes against the laser centers licensing by OSHA (a governmental organization that certifies that surgery centers are following the appropriate blood borne pathogen.  And I have to say that your organization will lose complete credibility if this type of action is excused.  These surgeons and the laser centers put their patients at severe risk. You can’t look back and say no one was injured, so their actions were OK.  Mad Cow Disease (Jacob-Creutzfeld) can be transmitted via the cornea (there are documented cases of patients transmitting this disease following corneal transplants) – and this disease may take 20-40 years to show up.  As well, HIV is known to be present in tears – and blood is not an uncommon sight with LASIK.”

Read More

“I thought surely the eye Doctors’ Academy (that provides the Doctors with the board certification they put in their bios) would have a policy designed to protect patients’ safety.  Think again.”

“At this time, the Academy [The American Academy of Ophthalmology] does not have a formal policy on the issue [reusing Microkeratome blades on multiple patients without sterilization].”

Read More

LasikFDA LAUNCHED

You Know Big Tobacco, Now Meet Big LASIK.

What do the LASIK industry and the tobacco industry have in common?  A smokescreen to hide the truth!

  • For many years, the tobacco industry depended heavily on advertising.  Big Tobacco marketed smoking as hip and cool.
  • The LASIK industry also depends heavily on advertising.  Big LASIK marketing portrays glasses and contact lenses as uncool and restrictive.  
  • Big Tobacco relies on peer-pressure from young people to entice their friends into the deadly habit of smoking.
  • Big LASIK relies on testimonials and word-of-mouth promotion.  LASIK patients are encouraged, and sometimes even paid, to refer friends and family members to have a medically unnecessary and risky surgery.
  • Big Tobacco sold a product which contains dangerous chemicals and an addictive drug, nicotene, which gives instant pleasure and satisfaction to users.
  • Big LASIK sells a harmful surgery which gives patients an immediate sense of joy and excitement (wow factor) when they realize they can see without glasses or contacts, leading to a high initial rate of satisfaction.   
  • Big Tobacco manipulated medical studies about the dangers of smoking.
  • Big LASIK manipulates medical studies and publishes junk science to cover up the dangers of LASIK.
  • Big Tobacco said that drinking one to two glasses of whole milk a day was riskier than second-hand smoke.
  • Big LASIK says that wearing contact lenses is riskier than having LASIK surgery. 
  • Big Tobacco advertised low-tar cigarettes as “the cigarette that takes the FEAR out of smoking.”
  • Big LASIK currently advertises blade-free LASIK as the technology that takes the FEAR out of LASIK.
  • Big Tobacco said that “unhappiness causes cancer.”
  • Big LASIK says that patient personality factors are to blame for LASIK dissatisfaction.
  • Big Tobacco attempted to silence and discredit its critics. Tobacco industry whistleblowers were threatened and harassed.
    Big LASIK attempts to discredit outspoken critics of LASIK. LASIK patients who speak out about problems with the procedure are threatened and harassed. 
  • Big Tobacco lied before Congress about the harmful health effects of smoking.
  • Big LASIK lied before the Food and Drug Administration about the harmful effects of LASIK.
  • Smoking can lead to cataracts, the number one cause of vision loss in the world.
  • LASIK can lead to cataracts.  Also, steriods drops routinely prescibed after LASIK may hasten onset of cataracts.  Ironically, LASIK complicates cataract surgery.
  • The damaging health effects of smoking are slow and insidious.  Smokers may not realize or acknowledge harm from cigarette use for years; nonetheless, the damage is there.
  • LASIK patients may suffer obvious and immediate complications, but some universal adverse effects of LASIK are insidious.  LASIK patients may not realize or acknowledge the harm they suffered from LASIK for years; nonetheless, the damage is there.
  • Tobacco use is the number one cause of preventable death in America.
  • LASIK is becoming a leading cause of preventable vision loss in America.

Big LASIK is selling a harmful, unnecessary surgery, and covering up the truth about LASIK risks and long-term adverse effects.  Don’t let Big LASIK blow smoke in your eyes.

Simply stated, its mission is “to expose deceit, corruption, and collusion by the FDA and the LASIK industry. You’ve read the hype about the 10-minute miracle. Now get the truth.”

The site contends that at that FDA panel meeting, “Insiders acquainted with the FDA approval process for medical devices were horrified as one by one, the presenters alleged deception by individual LASIK surgeons, cover ups perpetrated by medical device manufacturers, and corruption at the level of the FDA itself.

Compelling cases were made for massive violations of federal law, the failure of the FDA to monitor surgical facilities for LASIK, and deliberate misclassification of severe complications as simple side-effects, as a means of securing premature FDA approval of the excimer laser.

LINK TO SITE

Suggested reading:

1) The LASIK Report

http://www.thelasikreport.com

2) Top Ten Reasons Not to Have LASIK Surgery

http://www.lasikcomplications.com/TopTenReasons.htm

3) LASIK Newswire

LASIK Newswire

Are you really protected by the FDA?

Dom Morgan had LASIK which left him legally blind. When Morgan received documents from the FDA regarding his doctors’ improper use of an investigational FDA sanctioned laser, the less redacted reports were asked to be returned because “There was too much information the general public should not be aware of” and “was not only applicable to the Nevyases’ study, but all studies” (Quotes were from Les Weinstein, the Ombudsman of the FDA’s CDRH division).

The FDA’s Mission Statement: The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

In light of media attacks on the FDA the past couple of years or so regarding drugs, I find it most disturbing nobody really ventures into the area of medical devices, specifically lasers used for LASIK. You hear so many advertisements about the ‘good’ of this procedure, what about the ‘other side’?

Throughout this website I’ve explained what happened during the use of an Investigational Laser, and the results based on my experience. I’ve complained to the FDA since 2000 about my doctors’ study, their laser, what happened to me, and everything in between. For the first 3 years, I’ve been bounced from 1 person/department to another, and it wasn’t until December 2004, I finally got to have a conference with key personnel in the FDA CDRH’s Office of Compliance, the Office of Device Evaluation, and the Ombudsman. Too little, Too late!

The results of the meeting basically was that the doctors did not damage enough people to warrant disciplinary action (such as LaHaye), and that their study was no longer going on.

They were generous enough afterwards to release via the Freedom Of Information Act (FOIA) documents relating to 2 inspections of their facility, edited of course.

Those reports were asked to be returned because There was too much information the general public should not be aware of and was not only applicable to the doctors’ study, but of all studies“. I was told in order for the FDA to help me, I must help them, by returning the inspection reports.

Where was the help when I needed it most? Like BEFORE I and others were subjected to be a guinea pigs!

The inspection reports although edited, should have added credibility to what I’ve been saying all along. I believe these reports, along with all of the other documentation showed that the doctors involved:

Deviated from standard of Care during the length of their investigational study.

Violated standards, protocols, and federal regulations during this time.

Submitted false documents to their Institutional Review Board (IRB), and the FDA, regarding outcomes, adverse event cases, and enrollment in their study.

Told patients to get them included into their study, in telling them they were ‘good candidates’, when in fact they were not.

Performed LASIK on HUNDREDS of people prior to FDA’s approval for their IDE AND informed consent!

HOWEVER, months after receiving the inspection reports, documentation was submitted during discovery in the current litigation (which should have been produced during the med mal lawsuit) to prove the dates on the inspection reports wrong. How can the FDA offer protection to the people of the this country, when they make those kind of mistakes?

SPEAKING OF MORGAN’S FDA DEALINGS

BEFORE THE NEVYAS STUDY

It started with Ed Sullivan, the guy who built the ‘Nevyas Laser’, a man already under scrutiny by the FDA… “Ed Sullivan, doing business as ExSull, Drexel Hill, Pa, has been put on notice by the FDA that the agency regards him “clearly as a manufacturer with multiple manufacturing sites” subject to FDA rules and regulations and, if he makes another one of these excimer lasers “which are unapproved devices,” he will be in violation of the federal Food, Drug and Cosmetics Act and subject to legal penalties, according to top-ranking FDA officials within the national Division of Enforcement.” [as written in The Journal of Refractive Surgery – Volume 11 (5) * September/October 1995 * News, which was removed from the url address http://www.slackinc.com/eye/jrs/vol115/news1.htm].

And the FDA knew that! From the affidavit Herbert Nevyas submitted to the FDA, it tells of Ed Sullivan building their laser. However, documents show Mr. Sullivan in teleconferences and meetings with the doctors and their laison with the FDA well after this article was written.

After I received inspection reports even less redacted from the FDA regarding inspections of the Nevyas’ facility, the FDA promised “to do what they could to help me”, but then refused after copies of the inspection reports were returned. In fact Les Weinstein, the CDRH Ombudsman, outright told me (through his secretary) he could no longer have any communication with me.

The inspection reports of Sullivan’s facility below were obtained via the Freedom Of Information Act.  Regardless of these reports and the articles written concerning ‘Homegrown Lasers”, is this what the FDA considers “protecting the public’s safety”?

Click PAGE # to open pages in new window

PAGE 1 Previous inspection, 5/16/96, was a follow up to a Warning Letter issued on 8/17/95. The Warning Letter informed the firm that the FDA considered ExSull, Inc., to be a manufacturer of a Class III medical device, that was both adulterated and misbranded, in that there were no approved PMA or IDE for any of the devices and that the firm itself was not registered as a medical device manufacturer.

PAGE 2Mr. Sullivan stated that “he called the FDA and was sent material relating to the building of “custom devices”, and that the FDA person he had spoken to over the telephone assured him that it was okay to build them in the Doctor’s office”.

PAGE 3 Repeated attempts to schedule a subsequent meeting with Mr. Sullivan (via my leaving numerous messages on his voice mail) were unsuccessful. Mr. Sullivan would not commit to a date and time, when he returned my repeated phone calls, and in some instances did not even return my phone calls. Only after inadvertently meeting him at one of his client’s (on 6/25/97), did he then agree to see me at his ExSull, Inc.,

PAGE 4 Mr. Sullivan stated that he did not have any standard procedures for assembling the device. He stated that the device components are delivered to each physician’s office, where he then assembles the compete excimer laser. He informed me that he will then test the laser, but that he does not have any performance specifications, written assembly instructions or quality control tests.

PAGE 5and that any involvement by Mr. Sullivan in a sale, would depend on the nature of the sale. He would not elaborate on that statement, but explained that it means that he is not involved in every sale.

PAGE 6 Mr. Sullivan informed me that he has not contracted to build any additional units, since he assembled the device for [redacted] in October 1996. On 6/26/97, Mr. Sullivan showed me a copy of an IDE for that same client [redacted], Mr. Sullivan explained that he was working on the document, and an examination of the IDE showed that the unit had been used to treat at least [redacted] patients, without an approved IDE. Mr. Sullivan would not allow me to copy this document, and stated that the FDA already has this IDE on file.

PAGE 7 Mr. Sullivan did state that he will be publishing an article with a Dr. Herbert Nevyas, regarding the use of the ExSull, Inc., excimer laser for treatment of a patient with an irregular cornea, due to an eye injury.

PAGE 8 According to Mr. Sullivan, this entire process (the exchange of laser beam requirements and the design specifications) is all done via telephone or personal visits, and he does not have any written records of the design specifications. He stated that each individual physician should have those records. Mr. Sullivan stated that he knew of no injuries with the device. He did say that in theory the laser would have some patients possibly experiencing overcorrection, but that the majority would experience a slight undercorrection, which might require additional treatment. In addition, he explained that there has been no hazing or scaring, with the devices. He stated that the physicians handle all of the complaints from the patients, and that he is not aware of any major complications.

PAGE 9 Mr. Sullivan informed me that he designed the hardware for the “beam shaper” or “beam sculptor”, as well as, the software that controls that hardware. He stated that his program was written in [redacted]  and that three versions have been made, of that software. He informed me that he had no documentation or procedures for upgrading or changing the program (at the  [redacted]. In addition, he could not provide any information regarding which of the software versions are in any of the particular devices, stating that he did not keep any of those records.

PAGE 10 Mr. Sullivan gave his permission for me to observe the calibration procedure. I was allowed to examine the optical compartment, including the “beam shaper” or “beam sculptor”, designed by Mr. Sullivan. Mr. Sullivan would not let me photograph this part of the device.

PAGE 11 He informed me that he is only a consultant, and that each device he assembles is considered a “Custom Device”. He confirmed that he did not have any medical device manufacturing records, such as Master Device Record or Device History Record. I asked Mr. Sullivan if the firm had a Device Master Record or Device History Record. He responded that he considers himself a consultant, and that he does not keep any records of design specifications, manufacturing specifications or a device History Record. He stated that each of the physicians might have any documentation for the specifications or design, for their device.

PAGE 12 During the inspection, Mr. Sullivan stated that the firm’s computer, used to store all of the business records, had experienced a “hard drive crash”, in the winter of 1996. He explained that consequently all records from 1994 to December 1996 have been lost.

PAGE 13 He stated that he does not keep any repair or service log books, or a records of any complaints regarding the performance of the laser, by the physicians.

PAGE 14 There are no Exhibits with this EIR, due to the unavailability of records at the firm.

PAGE 15The observations noted in this FDA-4B3 are not an exhaustive listing of objectionable conditions. FDA 483 issued.

View ALL PAGES pdf document.

The FDA issued warning letters regarding the lasers Sullivan built, but STILL allowed doctors to further modify and use these devices on people considering LASIK!

Warning Letter 1 <>  Warning Letter 2

Nevyases Investigational Study

The following letters are from the FDA to Drs. Herbert Nevyas and Anita Nevyas-Wallace throughout their investigational study, and after their study was terminated. Despite continued deficiencies as noted below, the FDA kept granting the Nevyases Approvals for their study. Based on documents received during my med mal and the current Nevyas v. Morgan lawsuits, I believe the Nevyases constantly misrepresented themselves and their study to both Schullman Associates (the Nevyases IRB) and the FDA:

All BLUE font on this page designate links to documents which should open in new window.

May 1997

IDE Disapproval Letter from the FDA to Nevyases dated 05/08/97:

PAGE 1 The Food and Drug Administration (FDA) has reviewed your investigational device exemptions (IDE) application. We regret to inform you that your application is disapproved and you may not begin your investigation. Our disapproval is based on the deficiencies listed below.

PAGE 2 – Deficiencies listed.

PAGE 3 Please explain the low effectiveness and safety outcomes achieved in your prior clinical studies and specify what steps you are taking to improve your results. Your refractive and visual outcomes were reported at one month as: MSRE for low myopes, < 57% were within ID and < 35% were within 0.5D; less than 60% achieved BUCVA > 20/40; complication and adverse events occurred in > 2% of the cases.

PAGE 4 Please provide your agreement (or justification for not agreeing) that retreatments done to improve refractive outcome are NOT considered as treatment failures, whereas retreatments done to achieve resolution of an adverse event ARE considered as treatment failures.

PAGE 5 Your description of study procedures, examination conditions and techniques is not adequate. Please provide a detailed description of each procedure, test and instrument to be used in the study.

PAGE 6 For your follow-up visit schedule, the text on page 20 of the protocol appears to be inconsistent with the chart on page 43 of the protocol. In addition, please justify your statement on page 20 that measurement of corneal topography will be at the discretion of the investigator.

View ALL PAGES pdf document.

July 1997

Letter from the FDA to Nevyases dated 07/29/97 to cease using Laser:

PAGE 1 FDA is aware that a number of physicians are using lasers for refractive surgery to treat patients even though there is no PMA or IDE in effect for their lasers. Based on the results of our investigations, we believe that you are currently using your laser to treat patients.

PAGE 2 Accordingly, on July 28, 1997, we called you to notify you that use of your excimer laser to treat patients would violate the Act and requested that, if you are presently using the laser to treat patients, you immediately cease doing so.

Nevertheless, FDA does intend to consider any use of your laser to treat patients after the close of business July 28, 1997 unless and until the agency approves an IDE for your device to be grounds for disapproval of your IDE.

PAGE 3 We also want you to know that if FDA approves your IDE application, you would be able to use your laser to perform only specific procedures on a limited number of subjects to demonstrate the safety and effectiveness of your laser for those procedures. Studies conducted under such an IDE would be subject to all IDE regulations. See 21 C.F.R. Part 812. For example, you would be prohibited from promoting and commercializing the laser, and from representing that the device is safe and effective.

View ALL PAGES pdf document.

August 1997

‘Conditional’ Approval Letter from the FDA to Nevyases dated 08/07/97:

PAGE 1 Your application is conditionally approved because you have not adequately addressed deficiency #2 cited in our May 8, 1997 disapproval letter.

Also, we are in receipt of your certification (Amendment 4 received August 1, 1997) that you have not used the laser as of the close of business on July 28, 1997, and that you will not use the laser unless and until FDA approves the IDE applic2tion for your device

PAGE 2This approval is being granted on the condition that, within 45 days from the date of this letter, you submit information correcting the following deficiencies.

PAGE 3 – Deficiencies listed.

PAGE 4 – Deficiencies listed.

PAGE 5 We have enclosed the guidance document entitled “Sponsor’s Responsibilities for a Significant Risk Device Investigation” to help you understand the functions and duties of a sponsor.

View ALL PAGES pdf document.

October 1997

Letter from the FDA to Nevyases dated 10/03/97:

PAGE 1 We acknowledge receipt of your institutional review board (IRB) approval (supplement 3). Supplement 4 responds to our conditional approval letter of August 7, 1997 and requests: an increase crease in treatment range from -6.75 ID to -22 ID; approval to study simultaneous bilateral treatment; and, approval to retreat approximately 125 patients previously treated with this laser prior to IDE approval.

PAGE 2 Requests for additional subjects for enhancements for prior clinical patients will be evaluated as additional data is submitted to support stability of the procedure.

PAGE 3 You agree that you will not perform retreatment procedures for subjects initially treated under this IDE. Retreatment (enhancement) for subjects initially treated under this IDE is appropriate only after your preliminary data demonstrate safety and indicate the time point of stability of the procedure. You may begin retreatment procedures only after FDA has approved your retreatment study plan and data to support stability.

PAGE 4 PAGE 5 PAGE 6 PAGE 7 PAGE 8 PAGE 9 PAGE 10 – Deficiencies listed.

PAGE 11

View ALL PAGES pdf document.

December 1997

Approval Review Letter from the FDA to Nevyases:

PAGE 1 The Food and Drug Administration (FDA) has reviewed the supplement to your investigational device exemptions (IDE) application. Your application remains conditionally approved because your supplement adequately addressed only deficiency 2 cited in our October 3, 1997 letter.

This approval is being granted on the condition that, within 45 days from the date of this letter, you submit information correcting the following deficiencies.

PAGE 2 You are reminded that prior to a request for expansion beyond 150 subjects, you should provide adequate responses to deficiencies 5 16 in our letter of October 3, 1997.

View ALL PAGES pdf document.

FDA INVESTIGATIONAL STUDY AFFIDAVIT

The following pages are an Investigator Agreement issued by the FDA to a Sponsor/Investigator of an investigational study.  Nevyas refused to sign…

PAGE 1 – Investigator agreement signed by Anita Nevyas-Wallace

PAGE 2 – Investigator agreement signed by Herbert Nevyas

PAGE 3 – “I informed Mr. Kane, that Mr. Sullivan told me that the excimer laser that he would build, is considered a custom device and would not be regulated by the FDA. Mr. Sullivan completed the assembly of the laser in the fall of 1995, and the first patient was treated (using LASIK) in January 1996.

PAGE 4 – “I did not maintain any written records of the design specifications, nor did I receive any written design specifications from Mr. Sullivan.

PAGE 5 – “This patient is not part of the patient population included in my IDE submission. I have treated a total of 252 patients, from January 1996 to the present date (6/30/97),

PAGE 6 – “I affirm that the information on this and the previous pages, is accurate, to the best of my ability. I have read, but would not sign this affidavit.

View ALL PAGES pdf document.

Nevyases were issued an FDA483:

PAGE 1There was no documentation to show that the CI notified the IRB about all amendments, changes of significant deviations to the protocol [per IRB requirements] prior to implementation. For example, the FDA granted your firm an increase in the number of subjects you could treat with your investigational device on Jan. 20, 1999. IRB. Annual Review dated 7/29/00 does not indicate the IRB knew about population increase. The IRB did not approve the population increase until. August 28, 2000, 20 months later.

The firm is not complying with the Investigator Agreement which was signed and dated by the Clinical Investigator at the beginning of the Clinical Study.

There was a lapse of IRB approval for the protocol: NEV-97-001 from 8/3/2000 until 8/29/2000 according to IRB, lapse notices and the IRB annual reapproval letter.

January 1998

Approval Review Letter from the FDA to Nevyases:

PAGE 1In your “Substudy for Same-Day Versus Different Day LASIK Treatment for Fellow Eyes”: a. Please revise your informed consent document rider for same day surgery to state that the second eye will be rescheduled if there is a complication or an adverse event with the first eye.

PAGE 2 Your statement in the rider to the informed consent document that “…There have been no failures or malfunctions of the Willis Excimer Laser”, should be removed or altered. It may unduly influence potential same day fellow eye surgery candidates into believing that the Nevyas Excimer Laser cannot fail. FDA recommends that you remove this statement or alter it to read: “There have been no failures or malfunctions of the Nevyas Excimer Laser to date.”

PAGE 3

April 1998

Letter from the FDA to Nevyases dated 04/01/98 Re: Pre Market Approval (PMA):

PAGE 1 – Offers suggestions from the FDA should the Nevyases submit their PMA.

PAGE 2

May 1998

Approval Letter from the FDA to Nevyases dated 05/14/98 Re: Contrast Sensitivity & Increased ‘Subjects’:

PAGE 1 – ‘Conditional’ approval for substudy and increase of ‘subjects’.

PAGE 2 We acknowledge your request in your original IDE (dated March 18, 1997) to conduct a study at one site with 400 eyes low myopia and 590 eyes high myopia for each of two investigators (single site total of 1980 eyes or 990 subjects). We believe that adequate safety information has been provided to allow the initiation of your study with a small expansion of an additional 75 subjects (150 eyes). We will allow you to expand to the full number of subjects for this study (990) after you have received approval of supplements addressing the following deficiency from our letter of October 3, 1997 (enclosed). No additional expansions of your IDE will be granted until supplements containing the following information are approved:

PAGE 3You should also give serious consideration to the following items which are considered essential for the analysis of your data for the purposes of determining safety and effectiveness for a future PMA application: Deficiencies 5 through 16, excluding deficiency 14, in our letter of October 3, 1997.

July 1998

“Conditional” Approval Letter from the FDA to Nevyases:

PAGE 1FDA cannot approve your request as proposed because you have not shown stability of manifest refraction, and you have not presented sufficient detail for your hyperopic retreatment. FDA will conditionally approve, however, an expansion to include myopia and myopic astigmatism retreatments at this time.

PAGE 2This approval is being granted on the condition chat, within 45 days from the date of this letter, you submit your agreement to: 1. conduct the investigation within the modified limit, i.e., retreatment for myopia or myopic astigmatism only; 2. extend the minimum time between the initial operation and the retreatment to 3 months; and, 3. retreat only eyes which are “white and quiet” and in which refractive stability has been documented with two manifest refractions taken at least 30 days apart at less than 1 diopter of—change, confirmed by topography.,

PAGE 3

September 1998

Approval Letter from the FDA to Nevyases:

PAGE 1

PAGE 2

Nevyases’ Co-Investigators  (dated 10/01/98)

I started some time ago to contact the doctors on this LIST the Nevyases sent to the FDA, as being co-investigators. Three of those contacted who responded have never even heard of the Nevyases.

 

December 1998

Approval Letter from the FDA to Nevyases:

PAGE 1

PAGE 2

January 1999

Deviations of Nevyas Eye Associates, As Stated In Letter from the FDA dated 01/07/99:

PAGE 1Our review of the inspection report submitted by the district revealed deviations from Title 21, Code of Federal Regulations, (21 CFR), Part 812 – Investigstional Device Exemptions and Part 50 – Protection of Human Subjects and Section 520(g) of the Act. The deviations noted during the inspection were listed on form FDA-483, “Inspectional Observations,” which was presented to and discussed with you at the conclusion of the inspection.

PAGE 2Use of the Summit laser at your Marlton, New Jersey site for off-label procedures is not included in your IDE protocol. Moreover, enhancements approved under your IDE do not include hyperopic procedures. It is therefore considered a protocol violation to retreat subjects of your IDE study using the Summit laser and performing hyperopic LASIK.

PAGE 3While your Marlton, New Jersey site has a Summit laser, the advertisement does not specify a location. Future advertisements should specify the location(s) of approved lasers, as the enclosed advertisement would not be appropriate for soliciting subjects for your IDE study. All promotional materials designed to solicit participants or to inform subjects about the IDE study need to be approved by the reviewing IRB.

Approval Letter from the FDA to Nevyases dated 01/20/99:

PAGE 1Please be aware of the following: In Table 1-1, the data appear to be quite scattered, with some subjects actually increasing in sensitivity during glare (e.g., see BC & CB at 3 cycles per degree (CPD)), while others are severely compromised (see ZM). In order to reduce variability in the data in the contrast sensitivity study, the person administering the test should have experience in this test and the subjects should be well trained prior to testing.

PAGE 2We continue to be concerned that your ablation is likely to have multifocal properties, which means some light will be out of focus even at the best focal plane.

November 1999

Request Letter from the FDA to Nevyases:

PAGE 11. Please separate IDE subjects from pre-IDE subjects in all of your tables, or report only on IDE subjects.

PAGE 2

January 2001

Letter from the FDA to Nevyases Re: Non-Response To Request:

PAGE 1The Food and Drug Administration (FDA) granted approval of your investigational device exemptions (IDE) application on August 7, 1997. As part of your responsibilities as sponsor of a significant risk device investigation, you are required to submit a progress report to FDA and to all reviewing institutional review boards (IRBs) on at least a yearly basis. We have not received a response to FDA’s November 10, 1999 request for additional information regarding your August 1998 — August 1999 annual progress report (enclosed).

PAGE 2

April 2001

Request Letter from the FDA to Nevyases:

PAGE 1Please address the following questions/concerns, as well as provide the information requested in the tables enclosed with this letter.

PAGE 28. With regard to your future PMA submission, you have indicated that only subjects treated with the “new centration technique” will be included in the PMA, and that you have selected the eyes treated between 2/19/98 and 11/22/99 as the cohort to support the safety and effectiveness of the device. We would like to clarify that data from all subjects treated. under the IDE should be included in the PMA. The main PMA cohort on which the decision of the safety and effectiveness of the device will mainly rest may be limited to all eyes treated with the new centration technique, but not to only those enrolled during a given period of time, as you appear to have suggested.

PAGE 3

July 2001

Disapproval Letter from the FDA to Nevyases:

PAGE 1The Food and Drug Administration (FDA) has reviewed the supplement to your investigational device exemptions (IDE) application proposing two new clinical protocols to evaluate the spherical ablation algorithm. We regret to inform you that your supplement is disapproved and you may not implement the change in your investigation. Our disapproval is based on the following deficiencies which, unless otherwise specified, relate to both protocols:

PAGE 23. You have not provided in your protocol the methodology for performing any of the clinical evaluations. For each clinical evaluation, please specify the testing procedures and instruments that will be used, including the lighting conditions and charts you will use to measure distance vision and near vision, etc.

PAGE 37. Your protocol states that subjects must have a best spectacle corrected visual acuity (BSCVA) of at least 20/40 in each eye in order to be enrolled in the study. Please be advised that while we find this criteria acceptable for subjects with high myopia (>7 D MRSE), in order for subjects with low myopia (< 7 D MRSE) to be enrolled, we recommend a BSCVA of at least 20/25 in each eye. Please revise your protocol accordingly, or justify not doing so.

PAGE 421. The Conclusion section of the consent form stares, “There is always a possibility of one or more late complications That were not known or anticipated at the time of this writing (1997).” It also states, “LASIK is investigational surgery and as such, it has not yet been completely and exhaustively studied by the FDA and medical researchers in this country.” Please update the consent form as necessary in keeping with current knowledge including the additions previously mentioned. Please revise the second statement to Improve its accuracy: LASIK is no longer investigational, it has never (page 5) been studied by the FDA, and the FDA does not regulate LASIK, only the devices used for the procedure.

PAGE 528. There are discrepancies in the way you refer to the protocols throughout the submission. For example, in the Introduction you refer to the new protocols as NEV-97-002 (Myopia/Myopic Astigmatism) and NEV-97-003 (Hyperopia/Hyperopic Astigmatism). However, the myopia protocol itself has been labeled with the protocol number NEV-01-002. To avoid confusion, please make all necessary revisions in any future submission to correct such discrepancies.

PAGE 6With respect to the profiles of your ablated PMMA samples:

PAGE 7The deficiencies identified above represent the issues that we believe need to be resolved before your IDE application can be approved. In developing the deficiencies, we carefully considered the relevant statutory criteria for Agency decision-making as well as the burden that may be incurred in your attempt to respond to the deficiencies.

PAGE 834. Please be advised that for possible future pre-market approval, although 300 eyes total are needed to support overall safety, data from approximately 125 eyes are needed to support each indication for which approval is being sought.

August 2001

Supplement Disapproval Letter from the FDA to Nevyases:

PAGE 1We regret to inform you that your supplement is disapproved and you may not implement the change in your investigation. Our disapproval is based on the following deficiencies: 1. An important function of the software in the device is to control the beam delivery hardware (iris size, slot movement, synchronizing iris/slot with laser pulses, etc.) in the creation of an ablation pattern. This area, however, is not discussed at all in the Software Requirement Specifications document.

PAGE 2The deficiencies identified above represent the issues that we believe need to be resolved before your IDE application can be approved.

PAGE 3

February 2002

Nevyases Deviations and discrepancies continue almost 5 years into their study – Letter from the FDA to Nevyases:

PAGE 1Please address the following, questions and concerns with regard to this submission, which also applied to the previous, delinquent, annual report as outlined in FDA’s letter of April 10, 2001, and for which we never received a response:

PAGE 25. Please provide tables (similar to those requested for initial treatments) and narrative summarizing the results of the IDE substudy of enhancements for 25 subjects/50 eyes that had undergone treatment prior to implementation of the IDE, and of the data from enhancements performed for eyes enrolled under the IDE. Please provide separate analyses for the first enhancement, second enhancement, etc.

PAGE 31. Please note that, based on the stability analyses you have provided in this submission, we do not agree that the time point of stability is at 12 months postoperatively as you have indicated, and, in fact, may be earlier for some of the indications.

PAGE 4

April 2002

IDE Deficiencies Request Letter from the FDA to Nevyases:

PAGE 11. You must still provide responses to deficiencies 1, 2, 3, and 5 froth our letter of February 6, 2002. 2. You did not provide the requested information in your response to deficiency 4.

PAGE 24. In response to deficiency 8, you have indicated how you will verify your current accountability for visits that have already past. After your internal audit is complete and you have more insight as to the reasons for any problems with accountability, please directly address the original issue outlined in previous deficiency 8: please describe how you intend to improve subject follow-up and data reporting during the rest of the course of your IDE study.

PAGE 3 – Attachment: In a reply to Dr. Morris Waxler, FDA’s Chief Medical Device Examiner, Dr. Herbert Nevyas states “Since the close of business on July 28, 1997, neither I nor anyone else has used the laser. I certify that, unless and until FDA approves the IDE application for that device, neither I nor anyone else will use the laser to treat patients. I have notified all of my employees, as well as anyone with access to the laser, that the laser may not and will not be used until there is an approved IDE in effect for that laser. I declare that to the best of my knowledge the foregoing is true and correct.”

 

The following documents were submitted to the FDA from 1997 through 2001 regarding the “Nevyas Investigational (Black Box) Laser”

The laser was built by Ed Sullivan who, according to the excerpt below, was already under scrutiny by the FDA.

“Ed Sullivan, doing business as ExSull, Drexel Hill, Pa, has been put on notice by the FDA that the agency regards him “clearly as a manufacturer with multiple manufacturing sites” subject to FDA rules and regulations and, if he makes another one of these excimer lasers “which are unapproved devices,” he will be in violation of the federal Food, Drug and Cosmetics Act and subject to legal penalties, according to top-ranking FDA officials within the national Division of Enforcement.” [as written in The Journal of Refractive Surgery – Volume 11 (5) * September/October 1995 * News and was found at the url address: http://www.slackinc.com/eye/jrs/vol115/news1.htm”>http://www.slackinc.com/eye/jrs/vol115/news1.htm (no longer available).

Click PAGE # to open page in new window

NOTES: Page numbers with an “l” designate the page as landscape. All BLUE font on this page designate links. Some PDF documents may require a decrease in magnification for better clarity.

PDF Documents (for high speed or download)
To view ALL DOCUMENTS listed below in one PDF (two parts), click HERE.

1997 Reports

PAGE 1 – Prohibition of promotion and other practices. – 21 CFR. § 812.7

PAGE 2 – Protocol NEV-97-001: Myopia with or without astigmatism – Study Procedures.

PAGE 3 – Protocol NEV-97-001: Inclusion/Exclusion Criteria.

PAGE 4 – IDE Supplement – Question/Response.

PAGE 5 – Protocol NEV-97-001: Ethical and regulatory considerations.

PAGE 6 – Protocol NEV-97-001: Complications, Adverse Events, & Serious/Unanticipated Adverse Device Effects.

PAGE 7 – Protocol NEV-97-001: Inclusion/Exclusion Criteria Revision.

PAGE 8 – Protocol NEV-97-001: Screening for Refractive Surgery Eligibility.

PAGE 9 –  PAGE 10 – Protocol NEV-97-001: Clinical Study Data Submitted to FDA.

1998 Reports

PAGE 1 PAGE 2 PAGE 3 PAGE 4 –  PAGE 5 PAGE 6 PAGE 7 PAGE 8 PAGE 9 PAGE 10 PAGE 11 FULL – Protocol NEV-97-001: Study IDE Supplement Annual Report

PAGE 1 PAGE 2 PAGE 3 FULL – Protocol NEV-97-001: Study IDE Annual Report Supplement

PAGE 1 PAGE 2 PAGE 3 FULL – Protocol NEV-97-001: Study Changes, Progress towards PMA Approval, Safety & Efficacy for Study Eyes (Notice the 100% for cumulative UCVA of 20/40 or better, the 0 counts for the BSCVA worse than 20/40 or better, or for the BSCVA worse than 20/25, 6 months after my surgery).

1999 Reports

PAGE 1 PAGE 2 FULL – The FDA states “We continue to be concerned that your ablation is likely to have multifocal properties, which means that some light will be out of focus even at tine best focal plane“.

PAGE 1 PAGE 2 PAGE 3 FULL – Safety & Efficacy for Study Eyes, Page 1 (Notice the 100% for cumulative UCVA of 20/40 or better, the 0 counts for the BSCVA worse than 20/40 or better, or for the BSCVA worse than 20/25, 1 1/2 years after my surgery). The charts on pages 2 and 3 also do not show adverse events or complications.

2001 Reports

PAGE 1 PAGE 2 FULL – Protocol Deviations & Summary of Complications and Adverse Events.

PAGE 1 PAGE 2 PAGE 3 FULL – Nevyas Investigational Study charts submitted to the FDA.

PAGE 1 – The FDA states “There was no documentation to show that the CI notified the IRB about all amendments, changes or significant deviations to the protocol [per IRB requirements] prior to implementation” “The firm is not complying with the Investigator Agreement which was signed and dated by the Clinical Investigator at the beginning of the Clinical Study”; and “There was a lapse of IRB approval for the protocol: NEV-97-001 from 8/3/2000 until 8/29/2000 according to IRB, lapse notices and the IRB annual reapproval letter”.

Nevyas’ Promotion of An Investigational Device

Guidelines, regulations, and laws were in effect prior to the Nevyases’; investigational study.

Click PAGE # to open page in new window

NOTES: Page numbers with an “l” designate the page as landscape. All BLUE font on this page designate links.

From the Federal Trade Commission:

PAGE1 PAGE2 FULL – The FTC enforces the Federal Trade Commission Act (FTC Act), which among other things prohibits deceptive or unfair practices in or affecting commerce. 15 U.S.C. §§ 45, 52-57. An advertisement is deceptive under Section 5 of the FTC Act, and therefore unlawful, if it contains a representation or omission of fact that is likely to mislead consumers acting reasonably under the circumstances, and that representation or omission is material, that is, likely to affect a consumer’s choice or use of a product or service. It is important to note that advertisers are responsible for claims that are reasonably implied from their advertisements, as well as claims that are expressly stated.

In addition, under the FTC Act, advertisers must have substantiation for all objective claims about a product or service before the claims are disseminated In the context of claims about the safety, efficacy, success or other benefits of RK or PRK, substantiation will usually require competent and reliable scientific evidence’ sufficient to support the claim that is made.

From the Food and Drug Administration (FDA):

PAGE1 PAGE2 FULL – As you know, the FDA approved applications for premarket approval (PMAs) from Summit Technology, Inc. and from VISX Inc_ for their excimer lasers for the correction of mild to moderate myopia in patients with minimal astigmatism Based on the submitted data, these models were approved for refractive correction only by photorefractive keratectomy (PRK) of the corneal surface. Data were not submitted to support the use of these lasers for laser assisted in-situ keratomileusis (LASIK), laser scrape, astigmatism, hyperopia, or multipass or multizone software algorithms. Currently, these are the only lasers approved by FDA for refractive correction and the only refractive indications for which they are approved. The dioptric ranges indicated in the PMA are based on data submitted by these companies in their applications. Data on higher myopia and astigmatism were not submitted, and therefore the approvals did not provide for their treatment. All other lasers being used for refractive surgery, however manufactured or obtained, should be regarded as investigational devices and patients should have the usual human subject protection of institutional review board (IRB) protection, informed consent and an IDE approval by FDA.

21 C.F.R. §§ 812.7 Prohibits promotion of an investigational device!

21 C.F.R. §§ 812.7

CODE OF FEDERAL REGULATIONS

TITLE 21–FOOD AND DRUGS

CHAPTER I–FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN

SERVICES

SUBCHAPTER H–MEDICAL DEVICES

PART 812–INVESTIGATIONAL DEVICE EXEMPTIONS

SUBPART A–GENERAL PROVISIONS

§§ 812.7 Prohibition of promotion and other practices. A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not:

(a) Promote or test market an investigational device, until after FDA has approved the device for commercial distribution.

(b) Commercialize an investigational device by charging the subjects or investigators for a device a price larger than that necessary to recover costs of manufacture, research, development, and handling.

(c) Unduly prolong an investigation. If data developed by the investigation indicate in the case of a class III device that premarket approval cannot be justified or in the case of a class II device that it will not comply with an applicable performance standard or an amendment to that standard, the sponsor shall promptly terminate the investigation.

(d) Represent that an investigational device is safe or effective for the purposes for which it is being investigated.

However, the Nevyases DID promote:

On radio:

PAGE 1 PAGE 2 PAGE 3 PAGE 4 FULL – Nowhere did the Nevyases state that they were part of an investigational study or that their laser was also an investigational device.

And in an infomercial on MDTV:

PAGE 1 PAGE 3 FULL – The same applied to their infomercial.

FDA Inspection Reports of the Nevyases Facility

Click PAGE # to open page in new window

NOTES: Page numbers with an “l” designate the page as landscape. All BLUE font on this page designate links.

FDA Issued Inspection Report of Nevyas Eye Associates facility dated 11/02/1998:

PAGE 1 There was no documentation to show that the Cl notified the IRB about all amendments, changes or significant deviations to the protocol [per IRB requirements].

PAGE 2 Previous inspection on 6/30/97 of this facility revealed the firm continued to use the laser to perform eye surgery without an approved IDE, planned to use the laser or new treatment procedures not included in the firms disaproved IDE and verified that the firm had received a disapproval letter from CDRH/ODE notifying them that use of the laser to treat patients was a violation of the law.

PAGE 3 PAGE 4 – charts

PAGE 5 The current inspection revealed Clinical Investigator currently performs Myopic procedures under an approved IDE however, procedures are being performed on IDE patients prior to approval date, the date is missing on a consent form, consent forms were signed by patients after surgery date and procedures were performed on IDE patients which are outside the IDE with an unidentified laser at an unauthorized location.

PAGE 6 – Persons interviewed, individual resposibilities, & operations.

PAGE 7 – [Redacted] initial IDE submission was disapproved May 8, 1998. He was granted conditional approval on August 7, 1998. As [Redacted] addressed various issues presented in letters from FDA CDRH/ODE he was granted more uses of the IDE.

PAGE 8 – [Redacted] built the [Redacted] for [Redacted] however, [Redacted] owns it. He was responsible for submitting the information for the IDE, in conjunction with and eventually Pre-Market Approval for the device. He is therefore a Sponsor/Clinical Investigator.

PAGE 9These procedures were performed well before approval was granted. [Redacted] stated he had been doing this procedure previously and no one had told him the procedure couldn’t be performed as of 8/28/97.

PAGE 10Consent form for [Redacted] was not signed. There was no way of determining whether consent was obtained before or after surgery to the right eye on 12/4/97, due to lack of a date next to patients’ signature.

PAGE 11 – [Redacted] had [Redacted] enhancements performed which is a condition not indicated in the [Redacted]. Additionally, the procedures were performed with a laser that is not indicated in the study and the surgery was performed at a location that is not identified in the protocol.

PAGE 12There was no evidence of a patient information and consent form in the file for this hyperopic enhancement.

PAGE 13There was no documentation to show that the CI notified the IRB about all amendments, changes or significant deviations to the protocol [per IRB requirements].

PAGE 14According to a letter dated August 27, 1997, EXHIBIT #8 from the IRB, [Redacted] is required, in addition to other items, to report to the IRB any new advertisements, recruiting material, serious adverse events, amendments or changes to the protocol or significant protocol deviations. Observation # 6 represents a significant protocol deviation and should have been reported to the IRB for approval prior to implementation.

PAGE 15 PAGE 16 PAGE 17 PAGE 18 PAGE 19 – Lists exhibits included with inspection report.

View ALL PAGES pdf document
FDA Issued Inspection Report of the Nevyas’ facility dated 05/10/2001:

PAGE 1The firm is not complying with the Investigator Agreement which was signed and dated by the Clinical Investigator at the beginning of the Clinical Study.

PAGE 2An inspection conducted on 12/2/96 revealed the firm had assembled a single excimer laser and was using it to perform [Redacted] eye surgery on at least 120 patients without an approved IDE.

PAGE 3 – Persons interviewed, individual resposibilities, & operations.

PAGE 4According to a letter from the FDA to [Redacted] dated 1/20/99 EXHIBIT #1, the investigation is still limited to one location, listed in bold above however, the population has grown to 1015 subjects (2030 eyes):

PAGE 5For example, the FDA granted your firm an increase in the number of subjects you could treat with your investigational device on Jan. 20, 1999. IRB Annual Review dated 7/29/00 does not indicate the IRB knew about population increase. The IRB did not approve the population increase until August 28, 2000, 20 months later.

PAGE 6EXHIBIT #6 is an Investor Agreement which was signed by [Redacted] Sponsor/Clinical Investigator and [Redacted] Co-Investigator. The agreement indicates, among other things, the clinical investigators agree to promptly report to the IRB all changes in the research activity. The clinical investigators failed to report the increase in the number of study patients, granted by the FDA, to the IRB in a prompt manner.

PAGE 7I explained to [Redacted] that he did not have IRB coverage from 8/3/2000 until 8/29/2000. [Redacted] stated his consultant, [Redacted] was ill for several months and she normally took care of report submittals and updates which is why the firm was tardy with reporting updates.

PAGE 8 – [Redacted] stated it may appear that patients signed the consent forms one day after surgery however, this is certainly not the case and is not the way things are normally done. He indicated this was a mistake made by someone on his staff.

PAGE 9There was no documentation to show that the CI notified the IRB about all amendments, changes or significant deviations to the protocol [per IRB requirements]. This observation was carried forth to the current listing of objectionable conditions or practices. See FDA-483 observation #1 listed above on page #4 of this report.

PAGE 10All changes made to the protocol were documented by the investigator, dated, maintained with the protocol, however all changes were not approved by the IRB (see FDA-483 observation #1 listed on page 4 of this report).

PAGE 11 According to records reviewed, the investigator did submit and obtain IRB approval of the protocol, modifications to the protocol (except as noted in FDA-483 OBSERVATION #1),

PAGE 12 – Lists exhibits included with inspection report.

PAGE 13 PAGE 14 PAGE 15 PAGE 16 PAGE 17 – Nevyases response to inspection.

 “All adverse experiences have been reported to the sponsor-investigator, FDA, and IRB in accordance with 21 CFR Part 812“, and “The occurence of all events and complications as defined in Protocol NEV-97-001 have previously been reported to FDA. No serious adverse events related to the Nevyas Excimer Laser have occurred in the study”.

According to deposition by Anita Wallace, my visual problems post-lasik was not considered a complication or adverse event (I disagree!), even though she claimed the data regarding my situation was reported to the FDA. The charts submitted to the FDA listing adverse events and complications do NOT show data relevant to the number of medical malpractice claims filed against them during their study.

View ALL PAGES in pdf document

The 2nd inspection resulted in an FDA483 issued by the FDA.

Although the records requested via the FDA’s Freedom Of Information Act were redacted (edited), the FDA stated:

 “There is too much information the general public should not be aware of, not only in the Nevyas’ study, but in all studies”. – Les Weinstein, CDRH Ombudsman

This second set was obtained from the FDA’s Philadelphia Office, and included not only the Nevyas’ facility of 05/2001, but that of Ed Sullivan (Exsull), builder of their laser (see above). The inspection was 2 years after the article written in the Journal of Refractive Surgery (Fall Issue – 1995):

Inspection Report of the Nevyas’ facility dated 05/2001 (less edited):

PAGE 1 PAGE 2 PAGE 3 PAGE 4 PAGE 5 PAGE 6 PAGE 7 PAGE 8 PAGE 9 PAGE 10 PAGE 11 PAGE 12 ALL PAGES
 

FDA Oversight of Clinical Investigators

From the Department of Health and Human Services Office of the Inspector General

Purpose: To examine the FDA’s selection of clinical investigators for inspection and FDA’s discipline of those clinical investigators found in violation of FDA’s regulations. (June 2000)

READ THE REPORT

Did the FDA and ASCRS knowingly misrepresent the numbers of bad LASIK outcomes?

SOURCE

Reports of LASIK complications to the FDA’s

MedWatch
program (MAUDE Database) for medical device adverse events have nearly doubled since the public announcement of the the April 25th, 2008 Special Hearing of the Ophthalmic Devices Panel, held to discuss post-LASIK quality of life, depression, and suicide. At the hearing, two medical doctors, two optometrists, three psychologists, and a number of injured patients presented compelling information establishing a causal link between bad LASIK, depression, and suicide. Excerpts from two suicide notes were presented, including that of a medical student

(video: http://www.youtube.com/watch?v=UX855jmViaM) and that of a police officer who was well respected in his community

(video: http://www.youtube.com/watch?v=PBAqnVfJ5GU).

Over the past decade since LASIK was FDA-approved, the Agency has failed to enforce physician reporting of adverse events.  In March and April, 2008, patients were made aware of the voluntary reporting option by media reports of an upcoming FDA Special Hearing on LASIK problems.

The recent, rapid growth of complaints in the MAUDE database is, presumably, particularly embarassing for the American Society of Cataract and Refractive Surgery (ASCRS). In its April 7th, 2008 press release, ASCRS attempted to spin public perception of the Special Hearing by stating that ?Between 1998 and 2006, the FDA received a total of 140 comments relating to LASIK dissatisfaction, representing less than 1 in 10,000 U.S. LASIK patients.?

Unfortunately for ASCRS, nearly twice as many complaints have been received in the last six months as in the last ten years since LASIK’s approval.

The growth of complaints is also embarassing for the FDA, since some patients at the meeting charged that they are victims of an ongoing medical coverup, perpetrated by collusion between ASCRS and the FDA. Indeed, in its April 7th, 2008 press release, ASCRS stated that “The FDA reaffirms that LASIK is both safe and effective.” LASIK critics have responded to this assertion by asking publicly “When exactly was ASCRS authorized to make public announcements for the Food and Drug Administration?” (see

http://www.ascrs.org/press_releases/ASCRS-TO-PARTICIPATE-IN-AND-CO-FUND-STUDY-ON-POST-LASIK-QUALITY-OF-LIFE-WITH-US-FOOD-AND-DRUG-ADMINISTRATION.cfm
)

Three other sources of information strongly support collusion between ASCRS and FDA. First, prior to the Special Hearing, patients who came to the FDA?s website were encouraged to use a complaint form to report their vision issues and dry eye complaints to the FDA. Unknown to patients, these complaints were held by FDA CDRH, but were never registered in the MAUDE reporting system. Neither were they reported in the April 7th ASCRS press release. Why did the FDA CDRH choose to suppress these complaints? Was it to make LASIK look safer than it really is? Even though LASIK surgeons are required to report adverse events from LASIK to the FDA, most surgeons have apparently never filed a single report, despite the fact that ASCRS admits that up to 5% of patients are dissatisfied with their results.

Second, compare the ASCRS press release with a 2006 document issued by the FDA CDRH at

http://www.fda.gov/cdrh/postmarket/mdpi-report-1106.html
.

In this document, CDRH states frankly that “The data that are submitted via MDR rely upon a generation-old software platform (MAUDE) to organize, store and allow management of the data. This software, due to its age and limitations, does not allow MDR to serve its customers well. FDA staff and stakeholders report that MDR does not provide timely and usable data to staff or other system users?[and]?has a large
backlog of reports which hampers the ability to detect signals or identify problems.” Obviously, this document establishes that the FDA has long been aware of deficiencies in the MAUDE reporting system. Why, then, did the FDA allow ASCRS to speak for the agency? Why was ASCRS allowed to publicize deficient and inaccurate information in order spin public perception about the safety of LASIK? If the MAUDE system was known to be broken, why were complaints issued to the agency through its LASIK complaint form never counted?

Third, in November, 2006, the same month the FDA released criticism of its MAUDE reporting system, the FDA approached ASCRS and AAO to form a Joint LASIK Study Task Force in response to complaints sent to the FDA and Congress by damaged LASIK patients. Apparently, ASCRS surgeons had over 1.5 years notice of FDA?s intention to call a Special Hearing for LASIK post-market
issues.  In contrast, medical doctors, optometrists, psychologists, and injured patients who spoke on behalf of thousands of LASIK victims were not aware of the planned hearing until it was publicly announced in the Federal Register at the end of March, 2008. These individuals had just one month to prepare. Why did the FDA give the LASIK industry 1.5 years notice of the Special Hearing while patient groups and the public had only a one month notice?

Patient advocates want answers to these questions. So do thousands of damaged LASIK patients.

A Petition to BAN LASIK

Human Geneticist and Biochemist Lauranell Burch has filed a petition with the
FDA to ban LASIK. If you have complications from LASIK, you will want to
comment. Be sure to include any deception in how LASIK was sold to you,
inadequacy of informed consent, denial of your problems by your surgeon and
second opinion surgeon, your vision immediately after your surgery and your
vision now, and any feelings of depression and suicidal ideation, since these
are common in patients with severe complications. You can comment

HERE
.Due to enormous public outcry, the FDA is at last formally receiving general
comments on LASIK

HERE
. NOTICE:The FDA is currently assisting the LASIK industry in its
medical coverup by censoring many patient comments to the petition, in clear
violation of Federal Law. If you do not see your comment reflected, you now know
why.I submitted a response to the petition, as well as comment at another page
on the FDA’s site the beginning of September (08), to which nothing was posted.
I called the FDA to inquire and was told “no individual consumer’s response will
be posted”. In other words, unless you’re part of the industry, you have no say!
Poor excuses for censorship…

ASF FDA Medwatch Reporting Ignored or Unknown

ALL LASIK ASF’s (Ambulatory Surgical Facilities) were supposed to have been reporting  ALL PATIENT ADVERSE EVENTS (Complications, Side Effects, Patient Dissatisfactions, and Symptoms) to the FDA’s internal MEDWATCH database, but have not been doing so since 1997 (since LASIK)…Below is a recent deposition of a LASIK surgeon who testified as a defense expert in a LASIK malpractice lawsuit.  This is a perfect example of how LASIK surgeons completely ignore MedWatch reporting requirements:

SOURCE pages 74-76

 

Q. What role does the FDA play in refractive surgery?

A.  I don’t know the specifics of exactly what the FDA’s role is but they are responsible for making sure that the devices that we invent work well and they set up parameters for how to use those devices.

Q. Do you know what an adverse incident report is?

A. I have a general understanding of that.

Q. What is your general understanding?

A.  My general understanding is that if something happens that is significant and negative and unexpected.

Q. Something significant, negative and unexpected happens. What is the doctor’s obligation or the lasik surgeons obligation?

MR. STOTT: Object to the form.

THE WITNESS: I don’t know what you mean.

BY MR. BURNS:

Q. Do you have to tell the FDA?

I don’t know what those rules are. I don’t know.

Q. Have you ever notified the FDA of any adverse incident involving lasik surgery?

A. I’m not sure. The administrative side handles that. It’s by our admin staff.

Q. Who in your administration notifies the FDA if you have an adverse incident?

A. I don’t know.

Q. Up to this moment had you any suspicion that you were to suppose to notify the FDA of an adverse incident?

MR. STOTT: Object to the form.

THE WITNESS: I was aware that we do have to report certain things.

BY MR. BURNS: Q. What things do you understand that you have to report to the FDA?

A. I don’t know the details of what has to be reported to the FDA.

Q. Who have you assigned that responsibility to within the Woolfson Eye Institute?

A. I can find out who that is. We have someone in charge of operations and the admin side of that would be handled on that end.

Q. You don’t know whose job that is, if anybody, at Woolfson Eye Institute?

A. I don’t know who is responsible for reporting that to the FDA.

Q. Do you have something set up?

A. I believe we have something set up.

Q. Who set it up?

A. As I said it’s set up on the admin side.

Q. Who set it up?

A. I don’t handle the admin side.

Q. So you don’t know who set it up?

A. I don’t know who set up exactly what on the — administrative side.

Q. Is it your understanding that the adverse admin report should have been filed in connection with Kelly Leo’s case?

A. Again, I don’t know the exact details of what need to be reported to the FDA or not.

510(k) Route to Market Under New Attack

SOURCE  (reprinted with permission)

Two new pointers to the inadequacy of Sec. 510(k) to protect public health and safety emerged last week in a New York Times exposé of vaginal sling toxicity and new medical literature reporting elevated safety issues with new ophthalmic lasers. Both devices, substantially different from the “predicate” devices they referenced in their “substantially equivalent” 510(k) submissions to FDA, are now the subjects of liability or malpractice lawsuits. They add to a growing list of earlier examples of problems with 510(k) reviews in CDRH that cited other devices and are currently under Congressional scrutiny. One, ReGen Biologics’ Menaflex, is the focus of an internal FDA re-examination ordered by acting commissioner Joshua Sharfstein.

FDA’s current advice on what makes a device “substantially equivalent” relies on whether, “in comparison to a predicate, it:

  • has the same intended use as the predicate; and
  • has the same technological characteristics as the predicate;
    or
  • has the same intended use as the predicate; and
  • has different technological characteristics and the information submitted to FDA;
    • does not raise new questions of safety and effectiveness; and
    • demonstrates that the device is at least as safe and effective as the legally marketed device.”

In practice, a predicate can be a device that has been marketed for so short a period of time it has not established a meaningful safety record, and it can be a part of a string of such predicates.

The New York Times exposé cited adverse reactions leading to repeated surgeries for women using Mentor Corp.’s ObTape internally to control urinary leaks. The device was approved under a 510(k) that asserted it was “substantially equivalent” to older products, Johnson & Johnson’s Tension Free Vaginal Tape System and American Medical Systems’ Sparc Sling System which were themselves, in turn, 510(k)’d as “substantially equivalent” to J&J’s Protegen sling, recalled in 1999 and described by FDA then as “adulterated and misbranded.”

The newspaper recounted life-altering miseries characterized by persistent, painful and often bloody vaginal discharges, fear of cancer and a feeling that “I’m stuck with this for the rest of my life.”

According to the Times report, FDA declined requests for an interview and in an email answered that “Any legally marketed device can serve as a predicate for a premarket submission,” even if it has been recalled and called “adulterated and misbranded.” A subsequent 5/10 editorial said FDA “needs to take a hard look at whether it has been too lenient in clearing medical devices that may not be safe.”

In the ophthalmic lasers example, injured LASIK patients circulated on the Internet a Journal of Cataract & Refractive Surgery editorial by William J. Dupps, Jr. that commented on a University of Toronto clinical study of 149 eyes treated with a 15kHz Intralase femtosecond laser in which 56% were associated with an adverse event called opaque bubble layer (OBL). New-generation lasers with higher pulse frequencies may be less likely to cause OBL, Dupps said. All these devices entered the market through 510(k) clearances. Although OBL only rarely impacts visual acuity at three months post-procedure, it is part of a growing number of “a new array of complications” with femtosecond lasers, which are used to bladelessly create corneal flaps preparatory to LASIK reshaping. According to injured patients, these include corrugated corneal stromal bed, extreme light sensitivity, partial flaps, rainbow glare, torn flap, vertical gas breakthrough, epithelial ingrowth, flap necrosis, diffuse lamellar keratitis (DLK), corneal perforation, incomplete flap, decentered flaps, small flaps, slipped flaps, flap folds, traumatic flap dislocation, gas bubbles in the anterior chamber, optic nerve damage, flap tears, haze, macular hemorrhage, infection, stromal cell necrosis, inflammation, keratocyte cell death, corneal nerve damage, goblet cell reduction, and interface particles.

The Intralase devices were cleared on the basis of their “substantial equivalence” to a string of six other Intralase 510(k)’d predicates going back to 1999.

The study Dupps cited concluded that OBL was associated with thicker corneas and smaller corneal flaps and “did not seem to have detrimental long-term sequelae, although a small harmful effect could not be ruled out.”

Unlike the ObTape victims, the far more numerous injured LASIK patients support numerous Web sites and have formed networks in which they complain of permanent vision loss and a wide array of sight defects, inadequate or false advice from surgeons before undergoing the procedure, and FDA failure to investigate ambulatory surgical facilities for failure to report adverse events to FDA.

Responding to an FDA Webview request for comment on the vaginal sling and LASIK examples, FDA press officer Siobhan DeLancey said the majority of patients in both “report a positive outcome. However, we are aware that a small percentage of patients do experience serious adverse events. We released a Public Health Notification last fall about these surgical meshes used for stress urinary incontinence and pelvic organ prolapse (the indications mentioned in the NYT article), and that PHN can be found at http://www.fda.gov/cdrh/consumer/surgicalmesh-popsui.html. We are also in the process of a consumer education initiative on LASIK and held a public meeting last year to encourage the reporting of adverse outcomes. That information can be found at our advisory committee site (http://www.fda.gov/ohrms/dockets/ac/cdrh08.html#Ophthalmic, please see the information for the April 25, 2008 meeting).

“It’s important to note,” she continued, “that the report of an adverse event is not proof that a device caused the event. If the data reviewed by the FDA suggests a possible link between an adverse event and a device or use of a device, we may require further study before issuing a PHN or other health advisory.

“Adverse event data is not necessarily useful in making a direct correlation between a device and the event. The FDA uses this data to look for trends and safety signals of potential problems that most likely require further study and more intensive follow-up.”

On the LASIK issues, DeLancey said the agency had allowed a follow-up interview 5/14 by Consumer Reports with CDRH director of ophthalmic and ENT devices Malvina B. Eydelman. In that, Eydelman apparently provided a long list of FDA accomplishments since the 4/08 advisory committee meeting on patient injuries, including development of an FDA LASIK Web site; updating LASIK-related information in the SightNet program for health professionals to emphasize that halos, glare, night vision and dry eye problems from LASIK should be reported to FDA; developing a patient information card with the American Academy of Ophthalmology to help LASIK doctors calculate the lens implant power should they need to have future cataract surgery; recognizing the new LASIK standard from the American National Standards Institute; and opening a public docket for LASIK so that any interested person can pose comments, or concerns. This docket is web based and all comments submitted are able to be viewed by the public. All comments on the docket are examined and assessed by FDA staff on a regular basis.

“We are also working on collaborative agreements with organizations that have expertise in evaluating quality of life after LASIK,” DeLancey said. “We are currently collaborating with the National Eye Institute (NEI) on a pilot study to validate the web-based administration of previously validated paper versions of ophthalmic health-related questionnaires. Web-based administration of such questionnaires will help facilitate the pivotal study of patient-reported outcomes after LASIK.

“The pilot study is the first of its kind in the area of ophthalmology. Subjects with ocular surface disease and subjects with a normal ocular surface are being enrolled. People interested in participating in the pilot study at the NEI of the National Institutes of Health (NIH) in Bethesda, MD, and getting a free screening for dry eye and other ocular surface diseases, can learn more about the study by going to http://clinicaltrials.gov/ct2/show/NCT00678860?term=NCT00678860&rank=1.”

Patients feel FDA is disingenuous about interest in LASIK complications

SOURCE

LASIK is a 2.5 billion dollar per year industry.  LASIK is considered by some as the “gravy train” of ophthalmology.  Recently many questions have been raised about the frequency and severity of complications, and now many are wondering if LASIK really lives up to the hype.

In the past decade, several lasers have received FDA approval for use in LASIK surgery.  A report of data from FDA clinical trials for LASIK, including current technology, reveals that approximately 20% of patients report complications.1  The report shows that six months after LASIK, 17.5 percent of patients reported halos, 19.7 percent reported glare, 19.3 percent had night-driving problems and 21 percent complained of dry eyes.  It appears that if FDA had properly classified these “symptoms” as adverse events or complications, the devices would have failed to meet safety requirements for approval.

The FDA’s MedWatch program allows healthcare professionals and consumers to report adverse events associated with medical devices, such as those used to perform LASIK.  However, patients are not informed about the MedWatch program and there is no enforcement of reporting by physicians.  The inconsistency between the reported complication rates from LASIK clinical trials and the number of adverse events reported to the FDA through the MedWatch program clearly shows that complications from LASIK are grossly underreported.

Reports of widespread, serious problems with LASIK prompted FDA to hold a post-market meeting on April 25, 2008 to hear patient complaints and to accept recommendations from a panel of experts.  The panel was chaired by LASIK surgeon, Dr. Jane Weiss.  In her closing remarks, Dr. Weiss blamed the problems on “some surgeons who should be doing a better job”, rather the surgery itself.  Patients felt the hearing was a sham.

Two weeks before the FDA hearing, the American Society of Cataract and Refractive Surgery (ASCRS), a 10,000 member strong organization of ophthalmic surgeons, issued a press release stating the organization had formed a joint task force with FDA, National Eye Institute (NEI), and the American Academy of Ophthalmology (AAO) to conduct a prospective post-LASIK quality of life study.  The timing of the press release seems to indicate that the LASIK industry had inside information that the FDA had no plans to act swiftly on recommendations from the public at the hearing.  The unprecedented partnership between the LASIK industry and the FDA has raised eyebrows in the patient community.

These events followed on the heels of media reports of patients who experienced depression, and a report of suicide, due to complications from LASIK.  ASCRS fired back at the North Carolina newspaper that broke the story in February.  A flurry of bad press for the LASIK industry followed.  By early March, the LASIK industry had launched its damage control campaign by releasing preliminary findings from a meta-analysis of LASIK studies, which showed a 95% satisfaction rate.  Patients consider this meta-analysis a smokescreen to conceal the high rate of complications, such as dry eyes and night vision impairment.  Four suicides and numerous cases of depression related to LASIK were reported at the FDA hearing.

LASIK industry leadership subsequently announced the names of doctors who were hand-picked to design and conduct the post-LASIK quality of life study with the task force.  One of the doctors selected for the study is a well-known defense expert witness who testifies against LASIK patients who file medical malpractice lawsuits, has financial ties to the LASIK industry, and has made public statements that LASIK complications do not lead to depression.  Patients believe that all of the doctors chosen for the study are biased and lack objectivity, and that the study as proposed amounts to “the fox guarding the hen house”.

In a National Public Radio interview this week, Mary Weick-Brady, an FDA spokesperson, encouraged patients to report LASIK complications to the Agency using the MedWatch program.  Weick-Brady stated that halos, starbursts, and problems with night vision are considered adverse events.

The question that many damaged LASIK patients now want the FDA to answer is, how did a medical device with a 20% rate of adverse events receive FDA approval in the first place?

 

Reference:

  1. Bailey MD, Zadnik K. Outcomes of LASIK for myopia with FDA-approved lasers. Cornea. 2007 Apr;26(3):246-54.

 Help IS Available: Just Not In The U.S. 

With today’s advances in Refractive Surgery available in the United States, more damaged people are coming forward with complications from this procedure. Most complaints are quoted as incompetence, greed, ‘assembly line’ style surgical suites, lies to the patient, or the simple lack of caring by the doctor. First and foremost of complaints are the lasers! Just to name a few:

Blades getting stuck, broken, or RE-USED (these are supposed to be SINGLE USE BLADES);
Loss of the LASIK flaps (some have adhered to the microkeratome, some have been found ON THE FLOOR!);
Miscalculations by the doctors or techs;

There’s no good reason why Americans should be subjected to surgery with lasers inferior to those currently being used in Europe. Have a lasik evaluation and ask the doctor when he’ll have a new laser as good as the iVIS from Italy and a topographer equal to the Precisio. Don’t let him tell you that the differences are not substantial, because they ARE. Don’t settle for inferior equipment when your eyes are at stake. Your vision is too important.

Anyone considering refractive surgery should wait for that technology to become available in the United States. This is most important for patients who’ve already had refractive surgery and need irregular astigmatism, decentrations, small optical zones and other messes cleaned up. It appears that two doctors are at the forefront at helping those with bad outcomes who seek surgical remediation:

Dr. Ming Wang in Nashville, who is working on obtaining FDA approval* to import the iVIS laser into this country, and Dr. Aleks Stojanovic in Norway, who is already using the newer, better laser.

For more information, see the iVIS TECHNOLOGIES WEBSITE

If I were considering LASIK now, I’d wait because this technology is far superior to the crappy lasers in the U.S. right now. Not to mention our topographers that cannot see the central 1-2 mm of the cornea because the camera is in the way. Who in their right mind can honestly offer a custom treatment when data for the central cornea is being extrapolated?

* As mentioned throughout this section of my website, the FDA has done very little to help those damaged by Refractive Surgery. Apparently, there are no financial interests to the lackeys in the FDA by helping these casualties.

Will The FDA Ignore ANOTHER Petition?

The FDA over the years has been ignorant of many requests from those damaged by Refractive surgery. They continue their efforts to promote ‘effective’ responses, giving false hopes to those requesting help.

This petition involves the use and RE-USE of Microkeratome blades, that are supposed to be single use blades.

How would you feel if the person done before you was HIV+, or had some other contagious disease, and the blade was never changed?

Don’t let the FDA tell you this doesn’t happen, because it does, and it HAS been proven. Now let’s see how effective the FDA is in protecting you!

Please immediately take steps to approve the following Petition: I-VI to insure the safety of Americans regarding the misuses of Lasik going on in America today by refractive surgeons whom are stepping outside the ‘ethical’ limits on many levels regarding ‘breaching the standard of care’ we should all be given.

   
FDA According to “ LASIK Eye Surgery: What are the risks?,” an article published on the U.S. Food and Drug Administration web site, one of several risks of lasik surgery is the risk that “Some patients may develop severe dry eye syndrome. As a result of surgery, your eye may not be able to produce enough tears to keep the eye moist and comfortable. Dry eye not only causes discomfort, but can reduce visual quality due to intermittent blurring and other visual symptoms. This condition may be permanent.”
Ophthalmology Times According to “ Awareness facilitates treatment of LASIK-associated dry eye,” published in Ophthalmology Times in May 15, 2003), a study shows that “dry eye is both the most common complication after LASIK as well as the most common reason for patient dissatisfaction” and that “up to 80% of patients who undergo LASIK experience symptoms of dry eye postoperatively.”
Eric D. Donnenfeld, MD According to “Prevention and Management of Post-LASIK Dry Eye,” an online medical lecture dated March 2004 given by Eric D. Donnenfeld, MD, dry eye is a potential complication of lasik surgery. His first slide states: “The most common and potentially one of the most devastating … complications of LASIK is dry eye.” A later slide states, “Every patient gets dry eye after lasik.” He mentions severing of the corneal nerve as one possible cause of post-lasik dry eye, and also mentions several other possible causes, including specific surgical techniques.
SurgicalEyes.org According to SurgicalEyes.org, undergoing surgery to correct vision is reported to cause or increase dry eye pain for some people. The goal of the Surgical Eyes Web site is to assist people who have had unsuccessful LASIK, PRK, RK, AK, ALK or other elective refractive and laser surgeries.
DryEyeInfo.org According to the DryEyeInfo.Org Web site, people without Sjogren’s Syndrome can also have dry eye and thus dry eye pain: “Tear production can also decrease from any condition that decreases corneal sensation…. Causes for decreased corneal sensation include long-term contact lens wear, LASIK eye surgery, trauma to the 5th nerve, and certain viral infections.
LadarVision.com According to the LadarVision.com safety page, “People with the following conditions should not have LASIK: … Blepharitis (inflammation of the eyelids with crusting of the eyelashes….)” (and you might want to also take a look at the other conditions listed on that page). According to the LadarVision.com risks page, “In some cases, LASIK surgery may result in an inability to produce enough tears to keep eyes moist. This complication is the most common among LASIK side effects. Most patients suffer mildly from this for a short period of time…. The condition, however, can cause discomfort and may be permanent.”
Sjogren’s Syndrome Foundation newsletter (11/02) According to a Japanese study of 290 people who underwent LASIK surgery, some of whom had healthy eyes and some of whom were classified as having dry eyes or probable dry eyes, “patients with dry eyes can have significant dry eye symptoms, which may worsen after [LASIK] surgery. Those with probable dry eyes are also at risk for worsening dry eye criteria.”
Read The Petition

FDA Does Not Use Advisory Committees Effectively

FDA Does Not Use Advisory Committees Effectively in Approving New Drugs, Public Citizen Writes in Lancet Medical Journal

FDA Follows Committee Recommendations Only 72 Percent of Time, Does Not Present Its Own Reviews 18 Percent of Time

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) is not using its own advisory committees effectively when considering the approval of new drugs, according to a Public Citizen study, the results of which are published in a letter in the current edition of the Lancet medical journal. The study of drug advisory committee meetings found that the FDA overrules the findings of its own advisory panels 28 percent of the time, a figure higher than is generally assumed.

To read the entire press release, CLICK HERE

The FDA on Clinical Trials

It is well-known that manufacturers of devices (lasers, IOLs, etc.) cherry-pick the so-called top surgeons for clinical trials. It’s also well-known that surgeons cherry-pick patients for these clinical trials, including only patients who are likely to have the best outcomes. This is one reason why clinical trials do not really reflect the outcomes that will be seen in the real world in the hands of average surgeons and borderline patients. Let’s “listen in” on an FDA panel meeting:

http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3991t1.htm

Quote:

DR. WEISS: I think we have to be careful about this best physicians talking about lack of data. I’m sure these were good docs and good surgeons, but creating this extra godlike category, I think we should take out of the discussion.

DR. BANDEENROCHE: That’s a point welltaken. That’s a point welltaken. Nonetheless, I mean, we hardly expect better performance in the field than we do in a clinical trial.

DR. McCULLEY: You don’t have data to support that statement, do you? Do you have data to support that statement? You do. Okay.

DR. ROSENTHAL: With all kinds of devices.

DR. McCULLEY: All right.

DR. WEISS: What I would then like to lead to is since there’s agreement ‑‑

DR. ROSENTHAL: Wait.

DR. WEISS: Yes.

DR. ROSENTHAL: I want to make sure I said the right thing. Once they go out in the field, they tend to have more problems than they do within the clinical trial.

DR. McCULLEY: But you don’t have data to support that the people who do the trials are the best of the best.

DR. ROSENTHAL: No.

DR. McCULLEY: I think that is opinion ‑‑

DR. MACSAI: That’s my opinion.

DR. McCULLEY: That is Marian’s opinion, and it should not be in our discussions.

DR. WEISS: So we’re going to take out the “god” factor out of the discussion.

(Laughter.)

Notice how Dr. Rosenthal (now deceased), Division Director, tried to back up and cover his tracks because he let that comment slip out.

Why Not ALL of the Black Box Lasers?

The FDA has been very ‘choosy’ as to what actions they took against SOME in the LASIK industry regarding ‘Black Box’ Lasers.

Throughout the FDA section of this site, you’ll see the indifferences between what the FDA says, and the actions they TAKE.

The siezure of several lasers does not account for all of the others out there that have damaged numerous people. The FDA has even allowed Ed Sullivan, builder of these lasers, to be involved in conferences with the FDA and the doctors, even AFTER the scrutiny of ‘Black Box’ lasers.

Below is a video regarding Dr. Nick Caro of Illinois, whose practice has resulted in over 60 lawsuits and siezure of his laser by the FDA.

 

Did the FDA and ASCRS knowingly misrepresent the numbers of bad LASIK outcomes?

SOURCE

Reports of LASIK complications to the FDA’s MedWatch program (MAUDE Database) for medical device adverse events have nearly doubled since the public announcement of the the April 25th, 2008 Special Hearing of the Ophthalmic Devices Panel, held to discuss post-LASIK quality of life, depression, and suicide. At the hearing, two medical doctors, two optometrists, three psychologists, and a number of injured patients presented compelling information establishing a causal link between bad LASIK, depression, and suicide. Excerpts from two suicide notes were presented, including that of a medical student (video: http://www.youtube.com/watch?v=UX855jmViaM) and that of a police officer who was well respected in his community (video: http://www.youtube.com/watch?v=PBAqnVfJ5GU).

Over the past decade since LASIK was FDA-approved, the Agency has failed to enforce physician reporting of adverse events.  In March and April, 2008, patients were made aware of the voluntary reporting option by media reports of an upcoming FDA Special Hearing on LASIK problems.  

The recent, rapid growth of complaints in the MAUDE database is, presumably, particularly embarassing for the American Society of Cataract and Refractive Surgery (ASCRS). In its April 7th, 2008 press release, ASCRS attempted to spin public perception of the Special Hearing by stating that ?Between 1998 and 2006, the FDA received a total of 140 comments relating to LASIK dissatisfaction, representing less than 1 in 10,000 U.S. LASIK patients.? Unfortunately for ASCRS, nearly twice as many complaints have been received in the last six months as in the last ten years since LASIK’s approval.

The growth of complaints is also embarassing for the FDA, since some patients at the meeting charged that they are victims of an ongoing medical coverup, perpetrated by collusion between ASCRS and the FDA. Indeed, in its April 7th, 2008 press release, ASCRS stated that “The FDA reaffirms that LASIK is both safe and effective.” LASIK critics have responded to this assertion by asking publicly “When exactly was ASCRS authorized to make public announcements for the Food and Drug Administration?” (see http://www.ascrs.org/press_releases/ASCRS-TO-PARTICIPATE-IN-AND-CO-FUND-STUDY-ON-POST-LASIK-QUALITY-OF-LIFE-WITH-US-FOOD-AND-DRUG-ADMINISTRATION.cfm)

Three other sources of information strongly support collusion between ASCRS and FDA. First, prior to the Special Hearing, patients who came to the FDA?s website were encouraged to use a complaint form to report their vision issues and dry eye complaints to the FDA. Unknown to patients, these complaints were held by FDA CDRH, but were never registered in the MAUDE reporting system. Neither were they reported in the April 7th ASCRS press release. Why did the FDA CDRH choose to suppress these complaints? Was it to make LASIK look safer than it really is? Even though LASIK surgeons are required to report adverse events from LASIK to the FDA, most surgeons have apparently never filed a single report, despite the fact that ASCRS admits that up to 5% of patients are dissatisfied with their results.

Second, compare the ASCRS press release with a 2006 document issued by the FDA CDRH at http://www.fda.gov/cdrh/postmarket/mdpi-report-1106.html. In this document, CDRH states frankly that “The data that are submitted via MDR rely upon a generation-old software platform (MAUDE) to organize, store and allow management of the data. This software, due to its age and limitations, does not allow MDR to serve its customers well. FDA staff and stakeholders report that MDR does not provide timely and usable data to staff or other system users?[and]?has a large backlog of reports which hampers the ability to detect signals or identify problems.” Obviously, this document establishes that the FDA has long been aware of deficiencies in the MAUDE reporting system. Why, then, did the FDA allow ASCRS to speak for the agency? Why was ASCRS allowed to publicize deficient and inaccurate information in order spin public perception about the safety of LASIK? If the MAUDE system was known to be broken, why were complaints issued to the agency through its LASIK complaint form never counted?  

Third, in November, 2006, the same month the FDA released criticism of its MAUDE reporting system, the FDA approached ASCRS and AAO to form a Joint LASIK Study Task Force in response to complaints sent to the FDA and Congress by damaged LASIK patients. Apparently, ASCRS surgeons had over 1.5 years notice of FDA?s intention to call a Special Hearing for LASIK post-market issues.  In contrast, medical doctors, optometrists, psychologists, and injured patients who spoke on behalf of thousands of LASIK victims were not aware of the planned hearing until it was publicly announced in the Federal Register at the end of March, 2008. These individuals had just one month to prepare. Why did the FDA give the LASIK industry 1.5 years notice of the Special Hearing while patient groups and the public had only a one month notice?

Patient advocates want answers to these questions. So do thousands of damaged LASIK patients.

For the Refractive Surgeons who offer Botox

FDA‘s Botox Warning Falls Short

Statement of Sidney Wolfe, MD, Director of the Health Research Group at Public Citizen

Feb. 8, 2008 – Today, the Food and Drug Administration (FDA) reported that botulinum toxin (available as Botox and Myoboloc) has been linked to adverse reactions, including respiratory failure and death. This announcement comes just two weeks after Public Citizen petitioned the FDA to immediately increase its warnings about the serious risks of using Botox and Myoboloc. Adverse reactions can include paralysis of the respiratory muscles and difficulty swallowing (dysphagia), a condition that can allow food or liquid to enter the respiratory tract and lungs, causing aspiration pneumonia. Our analysis of FDA data found that the makers of the drugs had reported 180 U.S. cases of people developing serious conditions after receiving injections, including 16 deaths.

READ the entire statement.

FDA Praises Itself To Committee on Govt. Reform

SOURCE

Statement of Daniel Schultz, M.D., Director Center for Devices and Radiological Health Food and Drug Administration U.S. Department of Health and Human Services before Committee on Government Reform House of Representatives  

SEPTEMBER 26, 2006

INTRODUCTION

Mr. Chairman and Members of the Committee, I am Dr. Daniel Schultz, Director, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA or the Agency). I consider device safety to be of utmost importance and appreciate your invitation and the opportunity to discuss this issue. Let me say at the outset that I believe FDA currently has many tools to ensure the safety, effectiveness, and manufacturing quality of reprocessed, single-use devices (SUDs).

FDA has been actively engaged in the SUD reuse issue for some time, and our efforts have included research, outreach, pre-market review, inspections, and compliance investigations. We have held numerous public meetings and conferences with industry, healthcare professionals, and consumers over the years to determine the extent, magnitude, and changing nature of this practice. FDA has carefully evaluated and conducted research to develop the scientific basis for addressing SUD reprocessing. We have inspected third party reprocessors, evaluated and investigated reports of patient injuries, and reviewed numerous pre-market submissions. Taken together, the Agency believes that these efforts have provided, and will continue to provide, reasonable assurance of safety and effectiveness of reprocessed SUDs for patients.

BACKGROUND

I will begin with a brief overview of our regulatory authorities for medical devices. A medical device as defined by Federal law encompasses several thousand health products, from simple articles such as tongue depressors and heating pads, to cutting-edge and complex devices such as implantable defibrillators and robotic equipment for minimally invasive surgery.

The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic (FD&C) Act gave FDA specific authority to regulate the safety and effectiveness of medical devices. Medical devices are assigned to one of three “classes.” Class I is the lowest risk category of device and includes items such as adhesive bandages. Class II, or medium-risk category of device, includes devices such as intravenous catheters and powered wheelchairs. Class III is the highest risk category of device and includes devices such as heart valves and coronary stents.

THE REGULATION OF REPROCESSED SINGLE USE MEDICAL DEVICES

The reprocessing of SUDs is legally permissible in the United States under the FD&C Act. Currently, only Class I and II SUD device types have been cleared by FDA for reprocessing. No Class III SUDs have been cleared/approved for reprocessing.

In August 2000, FDA issued a guidance document for industry and staff entitled “Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals.” This document set forth FDA’s priorities for enforcing pre-market submission and post-market requirements for manufacturers who wished to market reprocessed SUDs. The guidance document stated that any third party or hospital reprocessor should comply with requirements pertaining to: registration and listing, medical device reporting, medical device tracking, medical device corrections and removals, the quality system regulation, labeling, and pre-market submission. Essentially, third party firms and hospitals reprocessing SUDs were placed in the same regulatory framework as original equipment manufacturers (OEMs).

Prior to issuance of this guidance, reprocessing of SUDs was frequently performed by hospital personnel without regulatory oversight or regard to the level of device risk. In addition, many third party reprocessors contracted with hospitals to perform similar tasks and these contractors did not consistently adhere to FDA’s Good Manufacturing Practice Requirements.

CHANGES ENACTED WITH MDUFMA

In 2002, with enactment of the Medical Device User Fee and Modernization Act (MDUFMA), Congress mandated a number of new requirements for SUD reprocessors including, for certain SUDs, the pre-market submission of data to the Agency that exceeded the requirements for OEMs. In addition to the requirements specified in our 2000 Guidance Document, certain reprocessed SUD types that potentially could pose the greatest risk of infection and inadequate performance following reprocessing and that were previously exempt from any pre-market submission requirements, are no longer exempt.  

MDUFMA also created a new type of pre-market submission, called a “pre-market report” (PMR), for Class III reprocessed SUDs that otherwise would have required a pre-market approval application. Among other information, a PMR must include validation data regarding cleaning, sterilization, and functional performance of the reprocessed device to ensure it is substantially equivalent to a legally marketed device. To date, only one PMR has been submitted to the Agency and it was later withdrawn by the firm.

In addition, MDUFMA required a change to FDA’s MedWatch voluntary and mandatory reporting forms (Forms 3500 and 3500A, respectively) to facilitate the reporting of adverse events involving reprocessed SUDs.

Finally, MDUFMA required, as of August 1, 2006, that reprocessed SUDs prominently and conspicuously bear the name, abbreviation, or symbol of the reprocessor on the device itself, on an attachment to the device, or on a detachable label, depending on the physical characteristics of the device and whether the device has been marked by the OEM.

PRE-MARKET REVIEW OF REPROCESSED SUDs

Under the FD&C Act, before introducing a device to market, manufacturers must submit a Notification of Intent to Market a Device (510k) and obtain FDA clearance, unless the device has been exempted. MDUFMA required FDA to identify previously 510(k)-exempt device types that, if reprocessed as a SUD, would now require 510(k) pre-market review, including the submission of validation data. In addition, MDUFMA required that FDA identify SUDs that were already subject to 510(k) pre-market requirements, but that would now also require the submission of validation data. Required validation data include cleaning and sterilization data, and functional performance data demonstrating that each SUD will remain substantially equivalent to its predicate device after the maximum number of times the device is intended to be reprocessed.

The criteria used to determine which reprocessed SUD types would no longer be exempt from pre-market notification requirements and would require 510(k)s with validation data, and which reprocessed SUDs already subject to the 510(k) requirements also would now be subject to the additional requirement of validation data are available on the Internet at: http://www.fda.gov/OHRMS/DOCKETS/98fr/03-10413.html.

Using these criteria, FDA identified all previously exempt “critical” and “semi-critical” devices that were high-risk. These devices would no longer be exempt from 510(k) requirements and SUD reprocessors of these device types would be required to submit 510(k)s with validation data and receive clearance in order to continue marketing these devices.

In addition, the requirements and the lists of devices that were newly subject to these requirements were published in the Federal Register. FDA has added other reprocessed SUD types to these lists as we become aware of information that warrants their inclusion.

On June 1, 2004, FDA issued a revised “Guidance for Industry and FDA Staff; Medical Device User Fee and Modernization Act of 2002, Validation Data in Pre-market Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices.” This document describes the types of validation data that FDA recommends be submitted on cleaning, sterilization, and functional performance of certain reprocessed SUDs to ensure that they are substantially equivalent to the predicate device. Additionally, this document describes the timeframe for FDA’s reviews of these validation data submissions, and what actions the Agency intends to take if it finds a reprocessed SUD to be Not Substantially Equivalent (NSE) to the predicate device.

As of September 2006, FDA has received nearly 200 pre-market notification 510(k) submissions for reprocessed SUDs. These submissions cover from one, to as many as several hundred, device models. Of the almost 200 submissions, approximately 67 percent have been cleared by FDA. The remaining were not cleared for such reasons as inadequate validation data, lack of necessary information from the reprocessor, withdrawal of the application by the submitter, or lack of response to FDA’s request for data. (Approximately 88 percent of 510(k)s for all other devices are cleared and approximately 3.4 percent are found NSE to the predicate device.)

COMPLIANCE ACTIVITIES

FDA’s inspectional program serves as a bridge between pre- and post-market activities. Since 2000, on average, FDA has conducted inspections of reprocessor firms once every two years, a rate considerably higher than the one inspection in four years for OEMs. Of the seven firms currently known to be reprocessing, all have been inspected within the last two years. FDA continues to evaluate newly registered firms to confirm whether they are performing SUD reprocessing and updates its inspectional plan as required.

POST-MARKET SURVEILLANCE FOR REPROCESSED SUDs

Post-market monitoring of device-related adverse events (AEs) and product problems is accomplished through the Medical Device Reporting (MDR) system. MDR reports include deaths, serious injuries, and device malfunctions. Healthcare facilities are required to report deaths suspected to be device-related to both FDA and the manufacturer/reprocessor. They are required to report serious injuries to the manufacturer/reprocessor.

FDA also receives voluntary reports, generally from healthcare professionals, through its MedWatch reporting system. As previously mentioned, under MDUFMA, the MedWatch reporting form 3500A was revised to include a data entry field (D to ask if the device associated with the reported event was a reprocessed SUD. This question was added to the form to enhance the Agency’s ability to quickly identify and investigate reports of problems associated with reprocessed SUDs.

FDA responds to reports of death or serious injury by investigating the report and taking appropriate follow-up actions as needed. Follow-up actions may include enforcement actions and/or the issuance of a public health notification to alert the healthcare community of the Agency’s concerns.

As you know, on January 24, 2006, I and others briefed this Committee about SUD reprocessing. At that time, we provided background information including the current regulatory framework and AE data. Specifically, we searched our Manufacturer and User Facility Device Experience (MAUDE) database for reports from October 22, 2003, to December 13, 2005, that were coded as adverse events associated with reprocessed SUDs. The search produced 176 reports of death, serious injury, and/or device malfunction; however, analysis of these reports did not disclose a clear causative link between a reprocessed SUD and subsequent patient injury or death.

In July 2006, the Agency updated the search to include all reports entered into the MDR, MAUDE, and MedWatch databases between December 2005 and July 2006. FDA has received a total of approximately 434 reports, including MedWatch forms, where the reprocessed SUD field was checked “yes.” Our analysis of these reports determined that many of the devices were not reprocessed SUDs. Rather, they were implanted devices or devices that were designed to be re-usable and, therefore, were not reprocessed SUDs. Of the 434 reports, approximately 65 reports actually involved or were suspected to involve reprocessed SUDs, and were reviewed by FDA. The final analysis of the reports found that the types of adverse events reported to be associated with the use of SUDs were the same types of events that also are being reported for new, non-reprocessed devices. Therefore, it was unclear whether the device, the medical condition of the patient, the medical procedure, or other confounding factors caused or contributed to the adverse event.

FEEDBACK FROM A SAMPLING OF MEDSUN HOSPITAL FACILITIES THAT USE REPROCESSED SUDs

FDA’s Medical Product Safety Device Network (MedSun) is comprised of over 350 hospitals that have been recruited and specifically trained to identify and report device problems. The hospitals in this program are broadly representative of U.S. healthcare facilities. FDA staff talked with representatives from more than 50 of these facilities to obtain feedback on their experience with using reprocessed SUDs.

The MedSun respondents who gave us feedback represented various occupations in hospitals, including materials management, biomedical and clinical engineering, risk management, infection control, surgical services, nursing staff, supply utilization, and equipment management. Staff being interviewed responded overwhelmingly that they view the use of reprocessed SUDs as providing a significant cost savings to their facilities and as being an environmentally sound practice.

There was considerable variation in the devices being reprocessed at the various facilities and the degree of acceptance of this practice by individual practitioners within the facilities. None of the participants we spoke with reported specific problems with SUD-related infections, but they also pointed out that, if an infection occurred, it would be difficult to discern whether the reprocessed SUD was the cause. It also is interesting to note that the participants did not report a greater concern with mechanical problems associated with reprocessed SUDs compared to un-reprocessed SUDs. In general, the participants had a favorable view of reprocessed SUDs used in their facilities. They also stated that they relied heavily on FDA oversight to ensure safety and effectiveness and to provide objective information on reprocessed SUDs.

ONGOING FDA ACTIVITIES

The Agency continues to review and assess the practice of reprocessing SUDs.

CDRH established an active internal work group to ensure that review scientists remain current with the evolving scientific literature and new consensus standards that are relevant to the reprocessing of SUDs.

CDRH has convened a second work group, called the “Post-market Issue Action Team,” to develop a long-term strategy for monitoring, evaluating, and communicating information about reused SUDs.

CDRH continues to submit reprocessor inspection requests to the Office of Regulatory Affairs to schedule inspections of reprocessor facilities to assess conformance with the Quality System Regulation.

CDRH periodically updates its reuse webpage so that healthcare facilities and providers will have current information on legally marketed, reprocessed SUDs. Recently, easy-to-read tables listing FDA requirements for specific reprocessed SUD types were added to the website. In addition, we improved accessibility and added instructions to the publicly searchable FDA pre-market databases. These databases allow the user to search in real-time for recent and past clearances. (http://www.fda.gov/cdrh/reuse/index.html)

CDRH regularly updates guidance to industry and FDA reviewers on validation data requirements for reprocessed SUDS.

CDRH regularly updates the list of reprocessed SUDs subject to the additional pre-market requirements imposed by MDUFMA.

CDRH is conducting research to develop/establish “acceptable” SUD cleaning criteria.

CDRH is collaborating with two local healthcare facilities to help monitor changes in the design of some SUDs and identify new SUDs being reprocessed.

On September 25, 2006, FDA published two rules: the direct final rule for Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data; and a proposed rule for Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data; Companion to Direct Final Rule (proposed rule). These amendments will help ensure that reprocessors submit the data, including cleaning, sterilization, and functional performance data, needed to demonstrate that their device is substantially equivalent to the predicate device.

CONCLUSION

Available data show that SUDs can be reprocessed with a reasonable assurance of safety and effectiveness. FDA believes that reprocessed SUDs that meet FDA’s regulatory requirements are as safe and effective as a new device. The law and regulations in place are designed to protect the public health by assuring that the practice of reprocessing and reusing SUDs is based on sound science. FDA continues to monitor the performance of these devices and to assess and refine our ability to regulate these devices appropriately.

Mr. Chairman, thank you again for the opportunity to address this important topic. I will be happy to answer any questions.

The FDA can only regulate devices, not doctors. That is their claim to protecting themselves against those already damaged by Refractive Surgery.

Guidance for Industry and FDA Staff – A Joke?

SOURCE

Keratome and Replacement Keratome Blades Premarket Notification [510(k)] Submissions

Document issued on: September 18, 2006

For questions regarding this document, contact Everette T. Beers at 301-594-2018 ext. 136 or by email at everette.beers@fda.hhs.gov.

U.S. Department of Health and Human Services Food and Drug Administration

Center for Devices and Radiological Health Diagnostics and Surgical Devices Branch Division of Ophthalmic, Ear, Nose and Throat Devices

Office of Device Evaluation

Contains Nonbinding Recommendations

Preface Public Comment

Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852.

Alternatively, electronic comments may be submitted to http://www.fda.gov/dockets/ecomments. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies Additional copies are available from the Internet at: http://www.fda.gov/cdrh/ode/guidance/ specifc address.html. You may also send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number (1604) to identify the guidance you are requesting.

2 Contains Nonbinding Recommendations

3 Table of Contents

1. INTRODUCTION…………………………………………………………………………………………………..1

The Least Burdensome Approach………………………………………………………………………………..1

2. BACKGROUND…………………………………………………………………………………………………….2

3. THE CONTENT AND FORMAT OF AN ABBREVIATED 510(K) SUBMISSION….2

4. SCOPE………………………………………………………………………………………………………………….5

5. DEVICE DESCRIPTION……………………………………………………………………………………….5

6. RISKS TO HEALTH………………………………………………………………………………………………7

7. PRECLINICAL ASSESSMENT……………………………………………………………………………..7

8. SOFTWARE VALIDATION…………………………………………………………………………………..9

9. ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY……………9

10. MATERIAL CHARACTERIZATION AND BIOCOMPATIBILITY…………………….10

11. STERILIZATION…………………………………………………………………………………………………11

12. LABELING…………………………………………………………………………………………………………11

APPENDIX – INFORMATION FOR REPLACEMENT KERATOME BLADES……………13

Contains Nonbinding Recommendations

1

Guidance for Industry and FDA Staff

Keratome and Replacement Keratome Blades Premarket Notification [510(k)] Submissions

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

1. Introduction

FDA has developed this guidance document to assist industry in preparing premarket notification submissions for keratomes and replacement keratome blades. The device is intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant. Keratomes, originally used during cornea transplant surgery, are now widely used during the laser refractive surgical procedure known as laser-assisted in situ keratomileusis (LASIK).

The Least Burdensome Approach

The issues identified in this guidance document represent those that we believe need to be addressed before your device can be marketed. In developing the guidance, we carefully considered the relevant statutory criteria for Agency decision-making. We also considered the burden that may be incurred in your attempt to follow the guidance and address the issues we have identified. We believe that we have considered the least burdensome approach to resolving the issues presented in the guidance document. If, however, you believe that there is a less burdensome way to address the issues, you should follow the procedures outlined in the “A Suggested Approach to Resolving Least Burdensome Issues” document. It is available on our Center web page at: http://www.fda.gov/cdrh/modact/leastburdensome.html.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

Contains Nonbinding Recommendations

2

2. Background

A manufacturer who intends to market a device of this generic type should conform to the general controls of the Federal Food, Drug, and Cosmetic Act (the act), including the premarket notification requirements described in 21 CFR 807 Subpart E, and obtain a substantial equivalence determination from FDA prior to marketing the device. (See also 21 CFR 807.81 and 807.87). This guidance document identifies the classification regulation and product codes for keratomes and replacement keratome blades (refer to Section 4. Scope). In addition, other sections of this guidance document provide additional information to manufacturers on addressing risks related to these devices in premarket notifications (510(k)s).

This document supplements other FDA documents regarding the specific content requirements of a premarket notification submission. You should also refer to 21 CFR 807.87 and “How to Prepare a 510(k) Submission” on FDA Device Advice at http://www.fda.gov/cdrh/devadvice/314.html.

Under “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications,” http://www.fda.gov/cdrh/ode/parad510.html, a manufacturer may submit a Traditional 510(k) or has the option of submitting either an Abbreviated 510(k) or a Special 510(k). FDA believes an Abbreviated 510(k) provides the least burdensome means of demonstrating substantial equivalence for a new device, particularly once FDA has issued a guidance document addressing that device. Manufacturers considering certain modifications to their own cleared devices may lessen the regulatory burden by submitting a Special 510(k).

3. The Content and Format of an Abbreviated 510(k) Submission

An Abbreviated 510(k) submission must include the required elements identified in 21 CFR 807.87, including the proposed labeling for the device sufficient to describe the device, its intended use, and the directions for its use. In an Abbreviated 510(k), FDA may consider the contents of a summary report to be appropriate supporting data within the meaning of 21 CFR 807.87(f) or (g); therefore, we recommend that you include a summary report. The report should describe how this guidance document was used during the device development and testing and should briefly describe the methods or tests used and a summary of the test data or description of the acceptance criteria applied to address the risks identified in this document, as well as any additional risks specific to your device. This section suggests information to fulfill some of the requirements of section 807.87 as well as some other items that we recommend you include in an Abbreviated 510(k).

Contains Nonbinding Recommendations

3

Coversheet

The coversheet should prominently identify the submission as an Abbreviated 510(k) and cite the title of this guidance document.

Proposed labeling

Proposed labeling should be sufficient to describe the device, its intended use, and the directions for its use. (Please refer to Section 14. Labeling for specific information that should be included in the labeling for devices of the types covered by this guidance document.)

Summary report

We recommend that the summary report contain:

Description of the device and its intended use

We recommend that you describe the performance specifications and, when appropriate, include detailed, labeled drawings of the device. Please refer to Section 5. Device Description for specific information that we recommend you include in the device description for devices of the types covered by this guidance document. You should also submit an “indications for use” enclosure.1

Description of device design

We recommend that you include a brief description of the device design requirements.

Identification of the risk analysis method

We recommend that you identify the risk analysis method(s) you used to assess the risk profile, in general, as well as the specific device’s design and the results of this analysis. (Please refer to Section 6. Risks to Health and Section 7. Hazards Assessment for the risks to health generally associated with the use of this device that FDA has identified.)

Discussion of the device characteristics

We recommend that you discuss the device characteristics that address the risks identified in this guidance document, as well as any additional risks identified in your risk analysis.

Description of the performance aspects

We recommend that you include a brief description of the test method(s) you have used or intend to use to address each performance aspect identified in Sections 5 – 13 of this guidance document. If you follow a suggested test method, you may cite the method rather than describing it. If you modify a suggested test method, you may cite the method

1 Refer to http://www.fda.gov/cdrh/ode/indicate.html for the recommended format.

Contains Nonbinding Recommendations

4

but should provide sufficient information to explain the nature of and reason for the modification. For each test, you may either (1) briefly present the data resulting from the test in clear and concise form, such as a table, or (2) describe the acceptance criteria that you will apply to your test results.2 (See also 21 CFR 820.30, Subpart C – Design Controls for the Quality System Regulation.)

Reliance on standards

If you choose to rely on a recognized standard for any part of the device design or testing, you may include either a:

• statement that testing will be conducted and meet specified acceptance criteria before the device is marketed; or

• declaration of conformity to the standard.3

Because a declaration of conformity is based on results from testing, we believe you cannot properly submit a declaration of conformity until you have completed the testing the standard describes. For more information, please refer to section 514(c)(1)(B) of the act and the FDA guidance, Use of Standards in Substantial Equivalence Determinations, http://www.fda.gov/cdrh/ode/guidance/1131.html.

If it is not clear how you have addressed the risks identified by FDA or additional risks identified through your risk analysis, we may request additional information about aspects of the device’s performance characteristics. We may also request additional information if we need it to assess the adequacy of your acceptance criteria. (Under 21 CFR 807.87(l), we may request any additional information that is necessary to reach a determination regarding substantial equivalence.)

As an alternative to submitting an Abbreviated 510(k), you can submit a Traditional 510(k) that provides all of the information and data required under 21 CFR 807.87 and described in this guidance. A Traditional 510(k) should include all of your methods, data, acceptance criteria, and conclusions. Manufacturers considering certain modifications to their own cleared devices should consider submitting Special 510(k)s.

2 If FDA makes a substantial equivalence determination based on acceptance criteria, the subject device should be tested and shown to meet these acceptance criteria before being introduced into interstate commerce. If the finished device does not meet the acceptance criteria and, thus, differs from the device described in the cleared 510(k), FDA recommends that submitters apply the same criteria used to assess modifications to legally marketed devices (21 CFR 807.81(a)(3)) to determine whether marketing of the finished device requires clearance of a new 510(k).

3 See Required Elements for a Declaration of Conformity to a Recognized Standard (Screening Checklist for All Premarket Notification [510(K)] Submissions), http://www.fda.gov/cdrh/ode/reqrecstand.html.

Contains Nonbinding Recommendations

5

4. Scope

The scope of this document is limited to the device described below, 21 CFR 886.4370, class I, product codes HNO (Keratome, AC-Powered), HMY (Keratome, Battery-Powered), and NKY (Blade, Keratome, Reprocessed).

§ 21 CFR 886.4370 Keratome.

A keratome is an AC-powered or battery powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.

Water jet keratomes (product code MYD) classified under 886.4370 are not within the scope of this guidance. Laser keratome devices classified under 21 CFR 878.4810, Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology also are not within the scope of this guidance. In addition, reprocessed single use devices—such as reprocessed keratome blades—have additional requirements for validation of the cleaning and sterilization process that are not discussed in this guidance.4

5. Device Description

We recommend that you identify your device by the regulation and product code described in Section 4. We recommend that you provide a description, as discussed below, of the technical specifications, principles of operation, and of any keratome blades used with your device.

A. Technical Specifications

1. We recommend you list, with references to drawings or photographs, all parts (and associated specifications) necessary to carry out the device’s intended use, including, but not limited to:

• console, handpiece, motors, keratome head, keratome blades, tubing, fixation ring, eye attachment mechanism;

• any interchangeable components used to change depth or diameter of the flap or width of the hinge (e.g., depth plates); and

• any items that can be ordered as optional add-ons.

2. We recommend you identify the material composition of device components and include references to your drawings or photographs.

4 See Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices, http://www.fda.gov/cdrh/ode/guidance/1216.html.

Contains Nonbinding Recommendations

6

3. We recommend you provide a physical description of the device (e.g., size, weight, dimensions) with legible dimensional drawings.

B. Principles of Operation

We recommend you describe the method of operation, including, but not limited to, the information described below.

1. The means by which the blade moves across the cornea to perform a cut, the:

• advancement rate of the blade (mm/sec)

• oscillation rate of the blade (rpm)

• manual, electric (AC or DC), or pneumatic motor, and specifications

• use of rails, gears, etc.

• description of any other movement of the blade.

2. A description of the cut produced, including the:

• type of hinge or flap (nasal or superior)

• methods and components used to produce variable hinge, diameter, or thickness, if appropriate

• nominal flap thickness(es)

• nominal flap diameter(s)

• nominal hinge widths(s).

3. The means by which the blade is halted for the creation of a hinge or flap (e.g., a mechanical stop or software control).

4. The means by which the keratome attaches to the cornea (e.g., a vacuum fixation ring), the vacuum produced, and the maximum intraocular pressure (IOP) achieved during fixation.

5. Any diagrams and pictures that illustrate the points above.

C. Keratome Blade We recommend you include a description of the keratome blade and blade holder, including, but not limited to:

1. An engineering drawing of the blade that includes the dimensions and tolerances of the blade (including width, length, thickness, and bevels), blade holder (if applicable), and the mounting holes in the blade (if applicable). Contains Nonbinding Recommendations

7

2. A complete description of the materials in the blade (e.g., types and grades) and in the blade holder that includes any applicable ASTM standards.

3. The identity of any residue (e.g., oils) remaining on the blade due to the manufacturing process.

4. The hardness and sharpness of the blade with a description of the tests employed to measure each.

6. Risks to Health In the table below, FDA has identified the risks to health generally associated with the use of the keratome and the keratome blades addressed in this document. The measures recommended to mitigate these identified risks are given in this guidance document, as shown in the table below. We recommend that you conduct a risk analysis to identify any other risks specific to your device and include the results of this analysis. The 510(k) should also describe the risk analysis method used. If you elect to use an alternative approach to address a particular risk identified in this document, or have identified risks additional to those in this document, you should provide sufficient detail to support the approach you have used to address that risk.

Identified Risk

Recommended Mitigation Measures

Inadequate Performance

Section 7. Preclinical assessment

Section 8. Software assessment

Section 12. Labeling

Inflammation and Infection (e.g., keratitis, epithelial ingrowth, debris in the interface)

Section 10. Material Characterization and Biocompatibility

Section 11. Validation of Cleaning and Sterilization

Section 12. Labeling

Electrical shock

Section 9. Electrical Safety Assessment

7. Preclinical Assessment

We recommend you provide data from validation testing of your keratome. This testing should address the accuracy, precision, and quality of the corneal flaps produced by your device, as well as the overall design of the device at a system level.

Contains Nonbinding Recommendations

8

A. Validation of Cut

We recommend you provide the mean flap thicknesses, flap diameters, and hinge widths when the keratome is used in a statistically justifiable number of pig or cadaver eyes (e.g., 30 eyes per diameter and thickness). We recommend you test all the combinations of flap thicknesses, flap diameters, and hinge widths. We also recommend you provide data showing the nominal values, mean values, repeatability limits (i.e., the variability associated with cuts on a series of eyes using the same device and operator), and reproducibility limits (i.e., the variability associated with several series of eyes using different devices and operators) for all measured quantities. A tabular format of this data is desirable. We recommend you fully describe all associated test methods. We also recommend you provide general comments on your results, specifically addressing:

• the quality of the stromal bed produced (smooth, saw tooth, rough or other appropriate description)

• quality of the flap produced

• any significant differences between the nominal and measured values, wide variances or outliers, if present

• any anomalies noticed during the testing or in the data

• why you believe the flaps, hinges and stromal beds produced by your device are clinically acceptable.

If the device is an epikeratome, we recommend you also perform testing to determine the percentage of successful flaps (i.e., no residual patches of epithelium and an intact flap), percentage of partial cuts, percentage of torn flaps, and percentage of eyes with cellular debris requiring additional scraping. (Note that flap thickness testing is not recommended for epikeratomes, but flap diameters and hinge widths should be validated as described above.) We recommend you fully describe all associated test methods and provide general comments on your results. Specifically, we recommend that your comments explain why the rates of unsuccessful flaps, partial cuts, torn flaps, and cellular debris you observe are clinically acceptable.

You may include any available clinical data to support the validation information recommended above for keratomes and epikeratomes.

Contains Nonbinding Recommendations

9

B. Validation of Device Design

We recommend you conduct system level validation testing to ensure all hardware and software systems in the device are functioning properly. We recommend you validate all alarms and warnings (e.g., warnings or alarms for insufficient vacuum or improper assembly) under realistic fault conditions. For more details on software validation, please refer to Section 8 below.  

8. Software Validation

Manufacturers of class I devices automated with computer software must comply with the requirements of Design Controls (21 CFR 820.30, Subpart C) under the Quality System Regulations, 21 CFR 820.30(a)(2)(i). In accordance with these requirements, you must perform design validation, which includes a software validation and risk analysis, where appropriate, and document the design validation results in your design history file as described under 21 CFR 820.30(g).

Please refer to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, http://www.fda.gov/cdrh/ode/guidance/337.html, for a discussion of the software documentation that you should provide. Please also refer to the General Principles of Software Validation, http://www.fda.gov/cdrh/comp/guidance/938.html, for a discussion of general principles that the FDA considers applicable to the validation of medical device software.

We encourage you to take advantage of any recognized software standards and provide statements or declarations of conformity as described in the FDA guidance, Use of Standards in Substantial Equivalence Determinations, http://www.fda.gov/cdrh/ode/guidance/1131.html. Please visit the following website to search for the standards that have been recognized when a medical device contains software, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.  

9. Electrical Safety and Electromagnetic Compatibility

We recommend you address the electrical safety and electromagnetic compatibility of your device by following both standards below or equivalent methods:

• International Electrotechnical Committee (IEC) standard IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety

• IEC 60601-1, Part 1-2: General Requirements for Safety – Collateral Standard:

Electromagnetic Compatibility – Requirements and Tests Electromagnetic compatibility (EMC) encompasses both emissions (interference with other electronic devices) and immunity (interference with device performance created by emissions from other electronic devices). We recommend you evaluate the EMC of your device as discussed below.

Contains Nonbinding Recommendations

10

Emissions

EMC testing should demonstrate that the device will not adversely interfere with the performance of other electronic devices (emissions). Testing should include radio frequency (RF) electromagnetic, low frequency magnetic, and conducted emissions testing.

Immunity

EMC testing should also demonstrate that the device will perform as expected in the presence of other electrical and electronic devices or other sources of electromagnetic disturbance (EMD) in the intended environment of use (immunity). The device should operate in an acceptable manner (few EMC standards require operation within specification) during and after exposure to various forms of electromagnetic disturbance. Testing should include:

• electrostatic discharge (ESD)

• radiated RF electromagnetic fields

• electrical fast transient and bursts

• surges

• conducted RF electromagnetic energy

• voltage dips, short interruptions, and voltage variations on power supply input lines

• low- frequency magnetic fields

• quasi-static electric fields.

We recommend that you test your device according to IEC 60601-1-2 Medical Electrical Equipment – Part 1: General Requirements for Safety; Electromagnetic Compatibility – Requirements and Tests (Second Edition, 2001) to demonstrate the EMC characteristics of your device.

10. Material Characterization and Biocompatibility

FDA recommends you conduct biocompatibility testing as described in the FDA guidance, Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing (the Biocompatibility guidance).5 We consider keratome blades as devices with limited contact with breached or compromised surfaces. We recommend you select biocompatibility tests appropriate for the duration and level of contact with your device. You should prepare samples for biocompatibility testing in a way that reflects the actual conditions of use (e.g., if the material will be heated during use, it should be heated to adequate temperature prior to testing). If identical materials and identical material processing are used in a predicate

5 http://www.fda.gov/cdrh/g951.html

Contains Nonbinding Recommendations

11

device with the same type and duration of patient contact, you may identify the predicate device in lieu of providing biocompatibility testing.

11. Sterilization

For single use devices that are provided sterile, we recommend you provide sterilization information described in the guidance entitled, Updated 510(k) Sterility Review Guidance K90-1.6 The device should be sterile with a sterility assurance level (SAL) of 1 x 10-6 using a sterilization cycle validated in accordance with the Quality System Regulation (QSR) 21 CFR Part 820. In addition, we recommend you provide a description of the packaging that maintains the device’s sterility.

If the device is reusable, we recommend you identify the method that you used to validate the cleaning, disinfection, and sterilization of your device. (See also Section 12. Labeling.) In addition, we recommend you specify any limit on the number of times re-sterilization and reuse can be done without adversely affecting the safety, effectiveness, or performance of the device.

12. Labeling

The premarket notification must include labeling in sufficient detail to satisfy the requirements of 21 CFR 807.87(e). The following suggestions are intended to assist you in preparing labeling that satisfies the requirements of 21 CFR Part 801.7  

Directions for use

As a prescription device, under 21 CFR 801.109, the device is exempt from having adequate directions for lay use. Nevertheless, under 21 CFR 807.87(e), we recommend providing clear and concise instructions that delineate the technological features of the specific device and how the device is to be used on patients. Instructions should encourage local/institutional training programs designed to familiarize users with the features of the device and how to use the device in a safe and effective manner.

The user’s manual should include instructions for cleaning and sterilization procedures, if appropriate.

Your labeling should include indications for use, for example:

A keratome is indicated for cutting the cornea prior to lamellar (partial thickness) transplant or to create a flap in the cornea prior to LASIK surgery or prior to another procedure requiring a corneal flap.

6 http://www.fda.gov/cdrh/ode/guidance/361.html.

7 Although final labeling is not required for 510(k) clearance, final labeling must comply with the requirements of 21 CFR Part 801 before a medical device is introduced into interstate commerce. In addition, final labeling for prescription medical devices must comply with 21 CFR 801.109. Labeling recommendations in this guidance are consistent with the requirements of Part 801.

Contains Nonbinding Recommendations

12

We also recommend that you include the nominal values, mean values, repeatability limits, and reproducibility limits for flap thickness, flap diameter, and hinge width in the user’s manual. You should also include the basic details about the study design (e.g., porcine or human eyes, sample size) used to determine these values.

Contains Nonbinding Recommendations

13

Appendix – Information for Replacement Keratome Blades

A. For each keratome, for which your blades are intended for use, we recommend you provide the:

• name of the keratome original equipment manufacturer (OEM)

• model of the keratome

• 510(k) number (if known) for each keratome.

B. We recommend you include a side-by-side comparison for each of your blades with each keratome’s OEM blade. We also recommend you address the following parameters for each of your blades and the OEM blades. For each comparison and each parameter in each comparison, we recommend you comment on the similarities between blades and explain the impact on blade performance of any differences you observe. We also recommend presenting each comparison clearly and separately; a tabular format is desirable.

1. Dimensions

We recommend you include a diagram (drawing or manufacturing blue print) of the device that illustrates the dimensions you have measured. We recommend you also include a key to the diagram (a tabular format is desirable) that shows the dimensions and tolerances for your device (blade, blade holder, keratome head, as appropriate). We recommend you provide all of the measurements (mean, standard deviation, and measurement precision for each) of the blade (length, width, thickness, and bevels), blade holder (if applicable), mounting holes in blade (if applicable), keratome head (if applicable), and any other specifications to compare your device and the OEM blades. We also recommend you measure a statistically justifiable number of your blades and the OEM blades, for example 30 blades.

2. Materials

We recommend you identify and compare (by ASTM standard, specification, type, grade, certificate of analysis, etc.) the materials in the final product of your blade and the OEM blade: the blade, blade holder (if applicable), and coatings on the blade (if applicable). We also recommend you identify any remaining substances on the blade due to polishing or sharpening.  

3. Hardness

We recommend you compare the hardness of the blade and the OEM blade and indicate the test used to measure the hardness.  

Contains Nonbinding Recommendations

14

4. Sharpness

We also recommend you compare the sharpness of your blade and the OEM blade and indicate the test used to measure the sharpness. Testing may combine photomicrographs and validation testing, or be stand-alone sharpness tests.

C. Preclinical Assessment: See Section 7. Preclinical Assessment. We also recommend you provide documentation of validation testing demonstrating the equivalency of your blade to the OEM. For each comparison and each parameter in each comparison, we recommend you comment on the similarities between the blades and explain the impact of any differences you observe on the blade performance.

D. Sterilization: See Section 11. Sterilization.

E. Labeling: See Section 12. Labeling. Labeling should include an indications for use that identifies the OEM manufacturers and model numbers your blades are intended for use with.

F. FDA recommends that manufacturers of replacement keratome blades include the accuracy, repeatability, and reproducibility information for all combinations of flap thickness, flap diameter, and hinge width compatible with the OEM keratome in the package labeling.

FDA’s Page on reuse: http://www.fda.gov/cdrh/reuse/

The LASIK Report…Will The FDA act?

We all know how the FDA reacts to factual findings…

THE LASIK REPORT

A Call for the Discontinuation of a Harmful Procedure

August, 2006

LASIK is one of the most commonly performed elective surgeries in the United States today. The public perception of LASIK is based largely on advertising, which is intended to entice patients to have surgery without disclosing risks, side effects and contraindications.

The perceived benefits of LASIK surgery are obvious, whereas risks and adverse effects are not. It is unwise to assume that a surgeon who has a financial interest in a patient’s decision to have LASIK will provide adequate informed consent.

LASIK is irreversible and may result in long-term, debilitating complications. There are permanent adverse effects of LASIK in 100% of cases, even in the absence of clinically significant complications. This is unacceptable in the context of an elective surgery when safer alternatives such as glasses or contact lenses exist.

I. BACKGROUND

In 1998, when the first laser received FDA approval for LASIK, little was known about complications and long-term safety of the procedure. Early clinical trials did not thoroughly examine adverse effects of LASIK.

Since that time, numerous medical studies have examined the risks of LASIK. It is now widely reported in ophthalmic medical journals that complications such as dry eye and visual disturbances in low light are common, and that creation of the corneal flap permanently compromises tensile strength and biomechanical integrity of the cornea.

In 1999 during the initial boom in popularity of LASIK, Marguerite B. McDonald, noted refractive surgeon and then-Chief Medical Editor of EyeWorld magazine, stated in an editorial:

Quote:

“We are only starting to ride the enormous growth curve of LASIK in this country. There will be more than enough surgeries for everyone to benefit if we keep our heads by sharing information openly and honestly and by resisting the temptation to criticize the work of our colleagues when we are offering a second opinion to a patient with a suboptimal result. Who was it who said, ‘When the tide comes in, all the boats in the harbor go up?’ “

Today some prominent refractive surgeons are finding superior outcomes and better safety profiles with surface ablations such as PRK and LASEK, which avoid creation of a corneal flap. Yet LASIK continues to be the most common refractive surgical procedure performed.

II. DRY EYE

A report by the American Academy of Ophthalmology published in 2002 stated that dry eye is the most common complication of LASIK surgery.1 Refractive surgeons are aware that LASIK induces dry eye, yet patients are not receiving full informed consent as to the etiology, chronic nature and severity of this condition.

Quote:

“My LASIK dry eye is not a minor problem, as downplayed by some ophthalmologists. It’s a disability. I estimate that I am blind approximately 10 percent of the time due to my eyes being closed because of the pain. At the time of my surgery, I was told only a small number of patients experience a complication from this procedure. There is substantial evidence that shows this crippling side effect to be relatively common.”

LASIK patient, David Shell, testifying before the FDA Ophthalmic Devices Panel in August, 2002.

Persistent Dry Eye and Quality of Life after LASIK

Patients elect to undergo LASIK surgery with the expectation of improved quality of life. Instead, many are living with chronic pain from LASIK-induced dry eye. The FDA website states that dry eyes after LASIK may be permanent (http://www.fda.gov/cdrh/LASIK/risks.htm). Patients should be informed that LASIK surgery severs corneal nerves that play a crucial role in tear production, and that these nerves do not return to normal. Inability to sense and respond to dryness may lead to ocular surface damage.

Medical Research on the Duration and Severity of Dry Eye

Dry eye disease is a painful, chronic condition for some patients after LASIK surgery. In 2001, Hovanesian, Shah, and Maloney found that 48% of LASIK patients reported symptoms of dryness at least 6 months after surgery, including soreness, sharp pain and eyelid sticking to the eyeball.2

A Mayo Clinic study published in 2004 demonstrates that 3 years after LASIK corneal nerves are less than 60% of preoperative densities.3

In 2006, researchers at Baylor College of Medicine reported the incidence of dry eyes six months after LASIK at 36% overall and 41% in eyes with superior-hinges.4 These findings were based on objective medical tests rather than patient questionnaires, which is significant as patients with nerve damage may not be capable of sensing dryness.

The scientific literature is replete with case reports and studies of LASIK-induced dry eye. This complication is widely recognized in the industry as the most common complaint of LASIK patients, yet the problem is downplayed in the informed consent process. Most dry eye therapies provide only marginally effective symptomatic relief. There is no cure for LASIK-induced dry eye. Internet bulletin boards with forums devoted to post-LASIK dry eye are a testament to this widespread, debilitating condition.

III. NIGHT VISION IMPAIRMENT

Millions of LASIK surgeries have been performed in the United States since its approval in 1998. Many patients now suffer from visual impairment at night. Some of these patients, especially those with large pupils, are unsafe to drive at night and can no longer live normal, independent lives.

Quote:

“When I drive to work every day, fighting the DC traffic I hear lots of great advertisements including the advertisements from the center that did my surgery talking about 95, 98 percent, whatever the percentage is of their patients who achieve 20/20 or 20/40 or better vision, and they consider that a success. I am considered a success by that criteria as well. However, in anything but extremely bright daylight I am visually impaired by starbursts, halos, multiple ghost images because of LASIK done on my 8-millimeter pupils.”

FDA approval of devices should include not only approval within a certain range of myopia or astigmatism or hyperopia but within a range of pupil sizes such that any use of that device outside of that pupil size should be considered against the FDA approval of that device.

LASIK patient, Mitch Ferro, testifying before the FDA Ophthalmic Devices Panel in July, 1999.

Unfortunately the FDA turned a deaf ear on this recommendation and did not place a pupil size limit on the approval, nor did it include large pupils in the list of LASIK contraindications. Instead, the FDA approved lasers for LASIK with watered-down cautionary language in the labeling regarding large pupils. Dissemination of this labeling to patients was mandated by the FDA but not enforced, which violated the right to full informed consent for many patients with large pupils.

Reduced visual quality in dim light is frequently reported by LASIK patients.1 Patients with pupils that dilate larger than the effective optical zone of the LASIK treatment are at increased risk for debilitating visual aberrations and loss of contrast sensitivity.5 Even patients with normal pupil sizes are at risk, as the laser loses efficiency on the slope of the cornea resulting in an effective optical zone that is smaller than intended.6 Newer laser technologies attempt to compensate by applying more laser energy in the periphery of the ablation, but this technique removes more corneal tissue, increasing the risk of surgically-induced keratectasia.7

In a study published in 2004, dark-adapted pupil sizes of candidates for refractive surgery were found to range from 4.3 to 8.9 mm with a mean diameter of 6.5 mm.8 This finding explains why many patients had severe nighttime visual aberrations in the early days of photorefractive keratectomy when optical zones as small as 4 mm were used. In an attempt to overcome pupil size/optical zone mismatch, the standard treatment zone was increased incrementally over several years. However, even the 6.5 mm optical zone commonly used today does not prevent aberrations in many patients with large pupils, or high corrections and associated small effective optical zones.

Image degradation and visual aberrations in low light after LASIK were predictable. These problems had been widely recognized and reported with previous refractive surgeries such as radial keratotomy (RK) and photorefractive keratectomy (PRK), and were related to pupil size.9 If refractive power is not consistent across the entire diameter of the pupil, visual aberrations and loss of contrast sensitivity result. After cataract surgery or refractive lens exchange, patients also report poor vision at night when the pupil dilates. As phakic IOLs begin to replace LASIK for high myopia due to safety concerns, the pattern of patients with large pupils experiencing night vision disturbances is consistent.

Public Health Concerns following LASIK Surgery

Dr. Leo Maguire forewarned of the threat to public health posed by impaired vision following refractive surgery.10 The following is an excerpt from an editorial published in the March, 1994 edition of the American Journal of Ophthalmology:

Quote:

“I hope the reader will now understand how a patient may have clinically acceptable 20/20 visual acuity in the daytime and still suffer from clinically dangerous visual aberration at night if that patient’s visual system must cope with an altered refractive error, increased glare, poorer contrast discrimination, and preferentially degraded peripheral vision. People die at night in motor vehicle accidents four times as frequently as they do during the day, and these figures are adjusted for miles driven. Night driving presents a hazardous visual experience to adults without aberrations. When we discuss aberration at night we are considering a possible morbid effect of refractive surgery.”

A Brief Chronology of Scientific Literature on Night Vision Impairment after Corneal Refractive Surgery

Factors responsible for visual impairment in low light following refractive surgery have been discussed in articles and reported in peer-reviewed studies for nearly two decades.

1987

“For a patient to have a zone of glare-free vision centered on the point of fixation, the optical zone of the cornea must be larger than the entrance pupil. The larger the optical zone, the larger the field of glare-free vision.”11

1993

“Optical zone diameters must be at least as large as the entrance pupil diameter to preclude glare at the fovea, and larger than the entrance pupil to preclude parafoveal glare.”12

1996

“At nighttime, when the pupil dilates, rays from treated and untreated areas of the cornea reach the retina at different foci and produce haloes.”13

1997

“Corneal modulation transfer function calculations suggest that a significant loss of visual performance should be anticipated following photorefractive keratectomy, the effect being the greatest for large pupil diameters.”14

1998

“…after PRK, the diameter of the entrance pupil greatly affects the amount and character of the aberrations…”15

1999

“Changes in functional vision worsen as the target contrast diminishes and the pupil size increases.”16

2000

“The increase in ocular aberrations was significantly related with the virtual pupil size.”17

“Thus, an optical system may have no refractive error in the center of the pupil and an increasing error in the annular zones surrounding the pupil center. The resultant image may be sharp for small pupil diameters but degrade as the pupil expands.”18

2002

“The relation between pupil size and the optical clear zone are most important in minimizing these disturbances in RK. In PRK and LASIK, pupil size and the ablation diameter size and location are the major factors involved.”19

The LASIK industry failed to take corrective action in response to scientific evidence regarding the importance of matching the effective optical zone to a patient’s pupil size. As a result, many LASIK patients are now permanently visually impaired in dim light.

IV. IATROGENIC KERATECTASIA

The cornea is under constant stress from normal intraocular pressure pushing outward. The collagen bands of the cornea provide its form and biomechanical strength. LASIK thins the cornea and severs collagen bands, permanently weakening the cornea. This results in forward bulging of the cornea, which may progress to a condition known as keratectasia, characterized by loss of best corrected vision and possible corneal failure requiring corneal transplant.

The FDA, laser manufacturers, and refractive surgeons are aware of limits on flap thickness, ablation depth, and diameter of the optical zone imposed by corneal biomechanics. When the FDA initially approved lasers for LASIK, it established a minimum of 250 microns of corneal tissue under the flap after LASIK surgery to prevent corneal instability and progressive forward bulging. Subsequent reports in medical literature indicate that 250 microns is not sufficient to ensure corneal biomechanical stability.20,21 In response, some surgeons stopped performing LASIK or raised the residual stromal thickness limit in their practices. However, the majority of surgeons continue to observe the 250 micron rule initially established by the FDA, even though this limit has been shown to be insufficient.

The 250 micron rule is often violated inadvertently during surgery, as microkeratomes that cut the LASIK flap are unpredictable and produce flaps of varying thickness.22 For this reason, flap thickness should be measured intraoperatively. Most surgeons have not incorporated this important measurement into the surgical procedure prior to ablation, which places patients with thicker flaps at increased risk.

Keratectasia may develop months or years following LASIK.23 Since most cases are never reported, the true rate of this devastating complication may never be known. The safest solution for patients would be to abandon LASIK altogether. It is important to remember that LASIK is elective surgery. There is no sound medical reason to place patients at risk of vision loss from unnecessary surgery.

V. LIMITED HEALING OF THE CORNEA FOLLOWING LASIK

The human cornea is incapable of complete wound healing after LASIK surgery. In 2005, researchers at Emory University found permanent pathologic changes in all post-LASIK corneas examined, including undulation of Bowman’s layer, spatial separation of the LASIK flap from the stromal bed, epithelial thickening over the wound margin, interface debris, and severed and severely disordered collagen fibrils.24 The study reveals that the healing response never completely regenerates normal corneal stroma.

Another recent study demonstrates that the LASIK flap produces a scar at the margin that is only 28.1% of the tensile strength of normal corneal stroma, and the flap itself heals to only 2.4% of normal tensile strength.25 The article reports that one author has lifted LASIK flaps out to 11 years after initial surgery, further attesting to long-term weakness of the LASIK interface wound. Reports of late flap dislocations suggest that LASIK patients are vulnerable to traumatic flap injury for life. 26

VI. OTHER COMPLICATIONS AND CONCERNS

Potential Complications

Other vision-threatening complications are seen following LASIK surgery such as infection, retinal breaks and detachment, macular holes and hemorrhage, optic nerve damage, diffuse lamellar keratitis, irregular flaps, flap folds and striae, slipped flaps, epithelial defects, and epithelial ingrowth. These and other complications may have severe, lasting adverse effects.

Inaccurate IOP Measurement after LASIK

The changes in corneal thickness and curvature following LASIK affect intraocular pressure measurements, resulting in falsely low readings. LASIK patients face lifetime risk of undiagnosed high intraocular pressure (glaucoma), a leading cause of blindness.

Cataract Surgery after LASIK

Like the general population, LASIK patients will develop cataracts later in life. The altered corneal surface following LASIK prevents accurate measurement of intraocular lens power for cataract surgery. This may result in a “refractive surprise” for LASIK patients following cataract surgery and exposes them to increased risk of repeat surgeries.

LASIK Results in Loss of Near Vision

Patients are routinely misinformed that they will require reading glasses after the age of 40 whether they have LASIK or not. Nearsighted patients who do not have refractive surgery actually retain the ability to see up close naturally after the age of 40 simply by removing their glasses. LASIK increases the need for reading glasses by changing the eye’s focus from near to distance. The loss of near vision after myopic-LASIK affects many daily activities, not just reading. LASIK patients over the age of 40 may discover they have simply traded one pair of glasses for another.

VII. PATIENT SATISFACTION

LASIK success is measured by the LASIK industry as uncorrected visual acuity under bright illumination. Patients seeking vision correction are most concerned with elimination of glasses or contact lenses, and are unaware what it means to lose visual quality. Patient surveys typically show a high level of satisfaction with LASIK. However, an alarming number of  ‘satisfied’ patients also report symptoms such as visual disturbances in dim light and dry eye.

In May, 2001, results from a questionnaire completed by PRK and LASIK patients revealed that 19.5% reported a worsening in functioning, 27.1% a worsening in symptoms, 34.9% a worsening in optical problems, 33.7% a worsening in glare, and 41.5% a worsening in driving.27

In one report, researchers suggest that factors such as the Hawthorne effect and cognitive dissonance may play a role in patient satisfaction following LASIK.28 The Hawthorne effect favorably influences patients’ survey responses merely because patients are aware that they are enrolled in a study. Cognitive dissonance is a change in one’s attitude or beliefs to eliminate internal conflict with negative consequences of an irreversible action.

VIII. NEWER TECHNOLOGIES

Wavefront-guided and wavefront-optimized LASIK

Newer laser technologies were designed to reduce induction of new aberrations and prevent night vision disturbances. As complications from current technologies generate bad publicity, pressures to develop and market alternative technologies emerge. “Real” complication rates are openly discussed, not when a procedure is popular, but rather when providers push newer, “improved” technology. The LASIK industry and LASIK surgeons aggressively promote new technologies as “safer and more effective”, blaming older technologies for past complications. Although the introduction of wavefront-LASIK was surrounded by hype, studies have shown that wavefront-guided and wavefront-optimized LASIK actually increase, not decrease, higher order aberrations, reducing visual quality in previously untreated eyes.29,30 A recently published review of literature on wavefront-guided LASIK concludes that evidence does not support claims that wavefront outperforms conventional LASIK.31 Wavefront, like previous forms of refractive surgery, fails to deliver on its promises.

Femtosecond laser flap creation (Intralase-LASIK)

Mechanical blade microkeratomes have been linked to flap complications and damage to the epithelium. The femtosecond laser keratome is currently promoted as a safer alternative. Studies have shown that the femtosecond laser produces flaps with smaller deviations from planned thickness than mechanical microkeratomes. However, it does not reduce most complications associated with the LASIK procedure and has been linked to extreme light sensitivity,32 a new complication of this technology. Femtosecond laser flaps are more difficult to lift than flaps created with a blade, which may result in a higher incidence of torn flaps.

The femtosecond laser keratome currently requires longer suction on the eye than blade microkeratomes to create the LASIK flap. The incidence of posterior vitreous detachment with blade microkeratomes is high, at 13% overall and 24% for patients with high myopia.33 Increased suction ring exposure associated with use of femtosecond lasers likely induces posterior vitreous detachment at even higher rates as well as other serious complications such as retinal detachment, macular hemorrhage, retinal vein occlusion, and optic nerve damage following LASIK.

A search of peer-reviewed literature reveals problems associated with the femtosecond laser such as slipped flaps, interface inflammation, flap folds, infectious keratitis, corneal stromal inflammation, delayed wound healing, macular hemorrhage, and gas bubbles in the anterior chamber after surgery.34-40 The FDA medical device adverse events database (http://www.fda.gov/cdrh/maude.html) contains numerous reports involving femtosecond laser keratomes.

IX. CONCLUSION

Patients are denied the whole truth about the negative effects of LASIK; therefore they are unable to give informed consent. The LASIK industry has been unresponsive to results of medical research, which should have resulted in a higher standard of care. Instead, LASIK surgeons have resisted raising the standard of care in order to maintain the potential pool of candidates and to protect themselves from liability.

The American Medical Association endorses certain principles of medical ethics. One principle states that: “A physician shall uphold the standards of professionalism, be honest in all professional interactions, and strive to report physicians deficient in character or competence, or engaging in fraud or deception, to appropriate entities.” (http://www.ama-assn.org/ama/pub/category/2512.html). The white wall of silence called for by Dr. McDonald in 1999 violates this principle.

There has been and continues to be a pattern within the refractive surgery industry placing patients’ interests secondary to financial interests. Medical doctors are ethically bound to put the best interests of patients first. LASIK is an unnecessary surgical procedure that permanently damages the eyes of every patient; therefore it is a violation of a primary principle of medicine, “First, Do No Harm”. As such, the practice of LASIK should be discontinued.

References

1. Sugar A, Rapuano CJ, Culbertson WW, Huang D, Varley GA, Agapitos PJ, de Luise VP, Koch DD. Laser in situ keratomileusis for myopia and astigmatism: Safety and efficacy. A report by the American Academy of Ophthlamology. Ophthalmology. 2002 Jan;109(1):175-87.

2. Hovanesian JA, Shah SS, Maloney RK. Symptoms of dry eye and recurrent erosion syndrome after refractive surgery. J Cataract Refract Surg. 2001 Apr;27(4):577-84.

3. Calvillo MP, McLaren JW, Hodge DO, Bourne WM. Corneal reinnervation after LASIK: prospective 3-year longitudinal study. Invest Ophthalmol Vis Sci. 2004 Nov;45(11):3991-6.

4. De Paiva CS, Chen Z, Koch DD, Hamill MB, Manuel FK, Hassan SS, Wilhelmus KR, Pflugfelder SC. The incidence and risk factors for developing dry eye after myopic LASIK. Am J Ophthalmol. 2006 Mar; 141(3):438-45.

5. Schwiegerling J, Snyder RW. Corneal ablation patterns to correct for spherical aberration in photorefractive keratectomy. J Cataract Refract Surg. 2000 Feb;26(2):214-21.

6. Hersh PS, Fry K, Blaker JW. Spherical aberration after laser in situ keratomileusis and photorefractive keratectomy. Clinical results and theoretical models of etiology. J Cataract Refract Surg. 2003 Nov;29(11):2096-104.

7. Mrochen M, Donitzky C, Wullner C, Loffler J. Wavefront optimized ablation profiles. Theoretical background. J Cataract Refract Surg. 2004 Apr;30(4):775-85.

8. Netto MV, Ambrosio R Jr, Wilson SE. Pupil size in refractive surgery candidates. J of Refract Surg. 2004 Jul-Aug;20(4):337-42.

9. Hjortdal JO, Olsen H, Ehlers N. Prospective randomised study of corneal aberrations 1 year after radial keratotomy or photorefractive keratectomy. J Refract Surg. 2002 Jan-Feb;18(1):23-9.

10. Maguire LJ. Keratorefractive surgery, success, and the public health. Am J Ophthalmol. 1994 Mar 15;117(3):394-8.

11. Uozato H, Guyton DL. Centering Corneal Surgical Procedures. Amer J Ophthal. 1987 Mar 15;103(3 Pt 1):264-75.

12. Roberts CW, Koester CJ. Optical zone diameters for photorefractive corneal surgery. Invest Ophthalmol Vis Sci. 1993 Jun;34(7):2275-81.

13. Alster Y, Loewenstein A, Baumwald T, Lipshits I, Lazar M. Dapiprazole for patients with night haloes after excimer keratectomy. Graefes Arch Clin Exp Ophthalmol. 1996 Aug;234 Suppl 1:S139-41.

14. Oliver KM, Hemenger RP, Corbett MC, O’Brart DP, Verma S, Marshall J, Tomlinson A. Corneal optical aberrations induced by photorefractive keratectomy. J Refract Surg. 1997 May-Jun;13(3):246-54.

15. Martinez CE, Applegate RA, Klyce SD, McDonald MB, Medina JP, Howland HC. Effect of pupillary dilation on corneal optical aberrations after photorefractive keratectomy. Arch Ophthalmol. 1998 Aug;116(8):1053-62.

16. Holladay JT, Dudeja DR, Chang J. Functional vision and corneal changes after laser in situ keratomileusis determined by contrast sensitivity, glare testing, and corneal topography. J Cataract Refract Surg. 1999 May;25(5):663-9.

17. Seiler T, Kaemmerer M, Mierdel P, Krinke HE. Ocular optical aberrations after photorefractive keratectomy for myopia and myopic astigmatism. Arch Ophthalmol. 2000 Jan;118(1):17-21.

18. Schwiegerling J, Snyder RW. Corneal ablation patterns to correct for spherical aberration in photorefractive keratectomy. J Cataract Refract Surg. 2000 Feb;26(2):214-21.

19. Fan-Paul NI, Li J, Miller JS, Florakis GJ. Night vision disturbances after corneal refractive surgery. Surv Ophthalmol. 2002 Nov-Dec;47(6):533-46.

20. Miyata K, Tokunaga T, Nakahara M, Ohtani S, Nejima R, Kiuchi T, Kaji Y, Oshika T. R. Residual bed thickness and corneal forward shift after laser in situ keratomileusis. J Cataract Refract Surg. 2004 May;30(5):1067-72.

21. Pallikaris IG, Kymionis GD, Astyrakakis NI. Corneal ectasia induced by laser in situ keratomileusis. J Cataract Refract Surg. 2001 Nov;27(11):1796-802.

22. Flanagan GW, Binder PS. Precision of flap measurements for laser in situ keratomileusis in 4428 eyes. J Refract Surg. 2003 Mar-Apr;19(2):113-23.

23. Lifshitz T, Levy J, Klemperer I, Levinger S. Late bilateral keratectasia after LASIK in a low myopic patient. J Refract Surg. 2005 Sep-Oct;21(5):494-6.

24. Kramer TR, Chuckpaiwong V, Dawson DG, L’Hernault N, Grossniklaus HE, Edelhauser HF. Pathologic findings in postmortem corneas after successful laser in situ keratomileusis. Cornea. 2005 Jan;24(1):92-102.

25. Schmack I, Dawson DG, McCarey BE, Waring GO 3rd, Grossniklaus HE, Edelhauser HF. Cohesive tensile strength of human LASIK wounds with histologic, ultrastructural, and clinical correlations.

J Refract Surg. 2005 Sep-Oct;21(5):433-45.

26. Cheng AC, Rao SK, Leung GY, Young AL, Lam DS. Late traumatic flap dislocations after LASIK. J Refract Surg. 2006 May;22(5):500-4.

27. Schein OD, Vitale S, Cassard SD, Steinberg EP. Patient outcomes of refractive surgery. The refractive status and vision profile. J Cataract Refract Surg. 2001 May;27(5):665-73.

28. Garamendi E, Pesudovs K, Elliott DB. Changes in quality of life after laser in situ keratomileusis for myopia. J Cataract Refract Surg. 2005 Aug;31(8):1537-43.

29. Kohnen T, Buhren J, Kuhne C, Mirshahi A. Wavefront-guided LASIK with the Zyoptix 3.1 system for the correction of myopia and compound myopic astigmatism with 1-year followup: clinical outcome and change in higher order aberrations. Ophthalmology. 2004;111:2175-2185.

30. Brint SF. Higher order aberrations after LASIK for myopia with Alcon and Wavelight lasers: a prospective randomized trial. J Refract Surg. 2005 Nov-Dec;21(6):S799-803.

31. Netto MV, Dupps W Jr, Wilson SE. Wavefront-guided ablation: evidence for efficacy compared to traditional ablation. Am J Ophthalmol. 2006 Feb;141(2):360-368.

32. Stonecipher KG, Dishler JG, Ignacio TS, Binder PS. Transient light sensitivity after femtosecond laser flap creation: clinical findings and management. J Cataract Refract Surg. 2006 Jan;32(1):91-4.

33. Luna JD, Artal MN, Reviglio VE, Pelizzari M, Diaz H, Juarez CP. Vitreoretinal alterations following laser in situ keratomileusis: clinical and experimental studies. Graefes Arch Clin Exp Ophthalmol. 2001 Jul;239(6):416-23.

34. Binder PS. Flap dimensions created with the IntraLase FS laser. J Cataract Refract Surg. 2004 Jan;30(1):26-32.

35. Biser SA, Bloom AH, Donnenfeld ED, Perry HD, Solomon R, Doshi S. Flap folds after femtosecond LASIK. Eye Contact Lens. 2003 Oct;29(4):252-4.

36. Chung SH, Roh MI, Park MS, Kong YT, Lee HK, Kim EK. Mycobacterium abscessus keratitis after LASIK with IntraLase femtosecond laser. Ophthalmologica. 2006;220(4):277-80.

37. Kim JY, Kim MJ, Kim TI, Choi HJ, Pak JH, Tchah H. A femtosecond laser creates a stronger flap than a mechanical microkeratome. Invest Ophthalmol Vis Sci. 2006 Feb;47(2):599-604.

38. Ratkay-Traub I, Ferincz IE, Juhasz T, Kurtz RM, Krueger RR. First clinical results with the femtosecond neodynium-glass laser in refractive surgery. J Refract Surg. 2003 Mar-Apr;19(2):94-103.

39. Principe AH, Lin DY, Small KW, Aldave AJ. Macular hemorrhage after laser in situ keratomileusis (LASIK) with femtosecond laser flap creation. Am J Ophthalmol. 2004 Oct;138(4):657-9.

40. Lifshitz T, Levy J, Klemperer I, Levinger S. Anterior chamber gas bubbles after corneal flap creation with a femtosecond laser. J Cataract Refract Surg. 2005 Nov;31(11):2227-9.

The FDA produced this quick and easy loophole to remove embarrassing little omissions from your PMA

– Did you forget a clause forbidding re-use of microkeratome blades?
– Need to change your labeling really fast to cover your behind?
IT is AMAZING how accomodating the FDA can be!

There’s MORE…

SOURCE

FDA > CDRH > MDUFMA >MDUFMA Guidance >Real-Time Premarket Approval Application (PMA) Supplements – Guidance for Industry and FDA Staff  

Real-Time Premarket Approval Application (PMA) Supplements – Guidance for Industry and FDA Staff Document issued on: April 28, 2006  

This document supersedes and replaces, the “Real-Time” Review Program for Premarket Approval Application (PMA) Supplements document last updated April 22, 1997 and Section II C, “PMA Supplements Definitions – Real Time Supplements” of the February 2003 guidance entitled, “Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products; Guidance for Industry and FDA”  

For questions regarding this document, contact Thinh Nguyen (CDRH) at 301-594-2186 or by e-mail at Thinh.Nguyen@fda.hhs.gov. For questions regarding the application of this guidance to devices regulated by the Center for Biologics Evaluation and Research (CBER), contact Leonard Wilson at 301-827-0373 or by email at leonard.wilson@fda.hhs.gov.  

U.S. Department of Health and Human Services Food and Drug Administration  

Center for Devices and Radiological Health  

Center for Biologic Evaluation and Research   

Contains Nonbinding Recommendations Preface Public Comment  

Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852.

When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated.  

Additional Copies  

Additional copies are available from the Internet at: http://www.fda.gov/cdrh/ode/guidance/673.pdf, or by phone at (301) 827-2000 or (800) 835-4709, or to receive this document by fax, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number (673) followed by the pound sign (#). Follow the remaining voice prompts to complete your request.  

Table of Contents

Purpose

Background

Which modifications are appropriate for a Real-Time PMA Supplement?

How do I request a Real-Time review?

Is there a user fee for a Real-Time PMA Supplement?

How do I submit a Real-Time PMA Supplement?

What should a Real-Time PMA Supplement contain?

What is the format of a Real-Time review meeting?

Attachment I. Sample Real-Time Review Request  

Guidance for Industry and FDA Staff Real-Time

Premarket Approval Application (PMA) Supplements

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.  

I. Purpose

This guidance provides information about the real-time review process for premarket approval application (PMA) supplements and outlines the procedures for requesting and submitting these types of documents. This guidance supersedes the document entitled “Real-Time” Review Program for Premarket Approval Application (PMA) Supplements, issued April 22, 1997 (the 1997 document) and Section II C, “PMA Supplements Definitions – Real Time Supplements” of the February 2003 guidance entitled, “Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products; Guidance for Industry and FDA.”  FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in Agency guidances means that something is suggested or recommended, but not required.  

II. Background

On February 4, 2003, FDA published a Federal Register notice entitled, “Medical Device User Fee and Modernization Act of 2002, Establishment of a Public Docket”1 to provide an opportunity for interested persons to share information and views on the implementation of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).2 Subsequently, FDA issued a guidance entitled “Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products”3 and invited comments on its topics, which included Real-Time PMA Supplements. FDA received no comments on Real-Time PMA Supplements in either docket.  

In revising the 1997 document, FDA considered the comments submitted on it and other comments about Real-Time review presented at the MDUFMA Annual Stakeholder Meetings.4 Our revision incorporates the criteria for Real-Time PMA Supplements set forth in section 737(4)(D) of the Federal Food, Drug, and Cosmetic Act (the act) and clarifies the kinds of device modifications we believe are appropriate for real-time review. We continue to invite comments on this guidance.  

The Least Burdensome Approach  

We believe we should consider the least burdensome approach in all areas of medical device regulation. This guidance reflects our careful review of the relevant scientific and legal requirements and what we believe is the least burdensome way for you to comply with those requirements. However, if you believe that an alternative approach would be less burdensome, please contact us so we can consider your point of view. You may send your written comments to the contact person listed in the preface to this guidance or to the CDRH or CBER Ombudsman. Comprehensive information on CDRH’s Ombudsman, including ways to contact him, can be found on the Internet at http://www.fda.gov/cdrh/resolvingdisputes/ombudsman.html and CBER’s Ombudsman can be reached at (301) 827-0379.  

III. Which modifications are appropriate for a Real-Time PMA Supplement?

According to section 737(4)(D) of the act,5 a Real-Time PMA Supplement is defined as:  

“a supplement to an approved premarket application or premarket report under section 515 that requests a minor change to the device, such as a minor change to the design of the device, software, sterilization, or labeling, and for which the applicant [PMA holder] has requested and the agency has granted a meeting or similar forum to jointly review and determine the status of the supplement.”  

In general, we believe a Real-Time PMA Supplement is appropriate for a minor change that can be expected within a product line, which includes changes to:  

device design

software

instructions for use, warnings, or precautions or other labeling that does not affect the indications or contraindications

sterilization and packaging methods.

In addition, a minor change should be one that is:  

expected for that device type

validated according to scientific principles we have relied on in previous reviews and accepted test methods or procedures for devices of that type, wherever applicable, such as an FDA-recognized standard or guidance document

adequately supported by pre-clinical or animal testing, with no new clinical data

typically involving review within a single scientific discipline, rather than a multidisciplinary review.

6 We also believe that for a Real-Time PMA Supplement to be an effective route to market, FDA and the PMA holder should agree that the review can be achieved in a “real-time” setting before either initiates the process.  

IV. How do I request a Real-Time review?

The typical request for a Real-Time review will follow these 4 steps.  

1. Preliminary Discussion  Before submitting your request, we recommend you contact the branch chief in the appropriate review division in CDRH or the applications division in the appropriate CBER office to discuss whether the modification to your device is appropriate for a Real-Time PMA Supplement.7  

2. Your Request  After you and FDA agree that the review can be achieved in a “real-time” setting, we recommend you fax your request for a Real-Time review to the appropriate CDRH branch chief or CBER applications division and follow with a hard copy to the Document Mail Center of the appropriate Center. We recommend that your request include the information outlined in the Sample Real Time Review Request in Attachment I.  

3. FDA’s Response  FDA plans to respond by fax within 14 days of receipt of Real-Time review requests to the Document Mail Center. Generally, if the information in your request is consistent with your preliminary discussion with FDA, and FDA, after evaluating the information, believes the modification is “minor” as defined in section III, FDA will grant your request.  

4. Type of Interaction  

We intend the review process for a Real-Time PMA Supplement to be interactive, although a face-to-face meeting may not always be part of the process. We will work with you to determine the type of interaction appropriate based on the information in your request. If you and FDA agree a meeting is appropriate, FDA’s response will also confirm a meeting date, which should be within 30 days of the proposed submission date of the supplement or the earliest date that both you and FDA personnel are available to meet.  

V. Is there a user fee for a Real-Time PMA Supplement?

Yes. As with all fee-paying submissions, the fee for a Real-Time PMA Supplement is due upon submission of the supplement. If FDA receives the supplement prior to payment, we will place the file on hold until we receive payment and notify you by facsimile.8 FDA begins its review when the Office of Financial Management notifies CDRH or CBER that payment has been received and we have received the PMA submission. See http://www.fda.gov/oc/mdufma for information on remitting user fees.  

VI. How do I submit a Real-Time PMA Supplement?

We recommend you submit at least 3 copies of your Real-Time PMA Supplement to the appropriate Center at the address below.  

Each copy should be labeled “REAL-TIME REVIEW REQUEST GRANTED” and contain a copy of FDA’s response granting your request for a Real-Time review.  

If we have scheduled a meeting with you, we recommend you submit your Real-Time PMA Supplement sufficiently in advance to allow FDA reviewers to adequately prepare their reviews. If we have not received your submission at least 3 weeks before the meeting, we will typically reschedule to assure reviewers have adequate preparation time in order to avoid an unproductive meeting.  

CDRH Review  

PMA Document Mail Center (HFZ-401)

Office of Device Evaluation

Center for Devices and Radiological Health

9200 Corporate Boulevard

Rockville, MD 20850  

CBER Review  

Food and Drug Administration

Center for Biologics Evaluation and Research

Document Control Center, HFM-99, Suite 200N

Rockville, MD 20852-1448  

VII. What should a Real-Time PMA Supplement contain?

A Real-Time PMA Supplement should identify all modifications planned for the device and labeling. We recommend you include testing and results, along with a detailed risk analysis to support the continued safety and effectiveness of the modified device. Your risk analysis should include a thorough assessment of all potential hazards associated with device use, taking into account the (incremental) modification proposed in your submission and the (cumulative) effects of any preceding modifications made since the approval of the original PMA. Your risk analysis should also identify the steps you have taken to minimize any additional risks that may be created by incremental or cumulative modifications.  

VIII. What is the format of a Real-Time review meeting?

If a Real-Time review meeting is part of the process, the meeting generally proceeds as follows:  

You present the changes to your device, results of testing to support those changes, and your risk analysis. You and FDA discuss any questions or comments about the changes, testing, or risk analysis. The meeting briefly adjourns to allow for discussion amongst FDA staff. FDA generally gives you verbal feedback that day. After the meeting, FDA will typically send our decision letter (i.e., approval, approvable, or not approvable letter) by fax, with a hard copy to follow.  

Attachment I. Sample Real-Time Review Request

PMA Contact Information and Submission Information

Date:  

Name:

Address:

Company:

Phone Number:

Fax Number:  

PMA Document Number:

Target Date for submitting to FDA:

Proposed Meeting Date(s):  

Reason(s) for submission (check one or more)  

__ Minor design changes  

__ Material changes to another known material  

__ Minor labeling changes  

__ Software change  

__ Sterilization changes to another known method  

__ Packaging changes  

__ Other  

We recommend that you attach a one-page or less explanation for the requested change(s) including:  

the test methods identified in FDA guidance or recognized standard, if applicable

identify under what submission we have previously reviewed these test methods, if applicable

a summary of your risk analysis

Specify the type of meeting you are requesting (check one or more)  

__ Face-to-face

 __ Telephone conference  

__ Video conference  

__ Other (Explain)   ——————————————————————————–  

1. 68 FR 5643  

2. Public Law 107-250  

3. Issued on February 25, 2003, see www.fda.gov/cdrh/mdufma/guidance/1201.html.  

4. Held December 3, 2003, November 18, 2004, and November 17, 2005.  

5. As amended by the Medical Devices Technical Corrections Act (Public Law 108-214).  

6. A review from a single scientific discipline may be, for example, an electrical engineering, mechanical engineering, chemical engineering, material engineering, microbiology, or biocompatibility review.  

7. For assistance in identifying the appropriate review branch in CDRH, the applicant may contact the Division of Small Manufacturers, International, and Consumer Assistance (DSMICA). Please see http://www.fda.gov/cdrh/devadvice/36f.html for contact options. For assistance in identifying the appropriate division in CBER, please contact the Office of Communication, Training and Manufacturers Assistance at 1-800-835-4709 or please see http://www.fda.gov/cber/inside/orgover.pdf.  

8. Section 102 of MDUFMA authorizes FDA to put the submission on hold until payment is received.  

Updated May 4, 2006

MORE FDA RELATED

FDA’s LASIK Website

Although I feel the FDA has protected many doctors, companies, and themselves, they still have somewhat of an an informative LASIK Website (Although I believe severely biased given the lack of authority to protect the public).

Link To Site

Is ANY Laser really safe?

Not just investigational lasers, but those WITH approval from the FDA…

Alcon lasers

There were a whole bunch of new MDRs filed in the Maude database during December about breakdowns of Ladarvisions. They make interesting reading. Go to:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm

(Type in “ladarvision” and search)

“CUSTOMCORNEA” into the search and got this one:  “Alcon customcornea & ladarvision 4000 wavefront lasik machines were used to preform enhancement surgery on left eye after original lasik in 2003. Enhancement surgery made eyesight worse; nearsighted again with multiple vision effect when looking at point of light. 2nd, 3rd, 4th opinions from other drs confirm irregularities in cornea from enhancement surgery and all of them say that the alcon customcornea wavefront measurement device and the ladarvision laser should not be used for enhancements because the software is not sophisticated enough and is too unstable.”  Not only their machines, but their stock as well:

http://finance.messages.yahoo.com/bbs?.mm=

FN&action=m&board=1604339425&tid=acl&sid=1604339425&mid=2932

CODE OF FEDERAL REGULATIONS 812.7

CODE OF FEDERAL REGULATIONS 812.7

And promotion of an Investigational Device.

Read More

FDA Warning for Risk of Dry Eye Complications

 

SOURCE

Quote:

Some patients may develop severe dry eye syndrome. As a result of surgery, your eye may not be able to produce enough tears to keep the eye moist and comfortable. Dry eye not only causes discomfort, but can reduce visual quality due to intermittent blurring and other visual symptoms. This condition may be permanent. Intensive drop therapy and use of plugs or other procedures may be required.

 

It does happen!  And the people I’ve spoken to with these complications let you know the risks are severely down-played by the FDA.  These symptoms are VERY painful!

 

And doctors want patients to think that DLK and infectious keratitis just happen for no reason…

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=41874

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=41818

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=25688

Ophthalmic Devices Panel Meetings

This FDA panel meeting has a rather disgusting section where concealing the fact that refractive surgery induces dry eye from the consumer is discussed. The panel decided not to require that ALCON disclose that dry eye after refractive surgery is an industry-wide problem… because they hadn’t required other LASER companies to include dry eye warnings in their labeling previously. So they claimed it wouldn’t be FAIR to ALCON to have to admit in their labelling that refractive surgery induces dry eye. How about being fair to patients so that they can be properly informed about LASIK dry eye BEFORE they decide to have surgery?

Loss of corneal nerve density averaging more than 40% at the 3 year point after LASIK? No thank you!

http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3883t1.doc

http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3883t1.doc

This link will allow you to find transcripts of all Ophthalmic Devices Panel meetings. Click on the year, then scroll down and look for Ophthalmic Devices.

http://www.fda.gov/ohrms/dockets/ac/acmenu.htm

Before you start clicking and reading, it helps to know which meetings were called to review lasers for refractive surgery.

Here’s a link to the summaries of these meetings from 1997 through 2000:

http://www.fda.gov/cdrh/odp.html

More recent meeting summaries can be found at this link:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/search.cfm

Click on “Ophthalmic Devices Panel”, “Past Meetings”.

Past FDA Actions showed industry bias from the very beginning:

When Charles Casebeer began the PMA presentation to the FDA panel, he stated he had “…no financial interest in any of the products involved…”

But!  Did Casebeer have a financial interest in any related product?  Namely, the LaserSight microkeratome?

Do you find it odd that in the fall of 1998, Dr. Casebeer speaks of his part in developing a keratome that was marketed by LaserSight in the article on the Refractive Eye Care website?

http://refractiveeyecare.com/0205-casebeer.pdf

“I put almost two years into helping to develop the Ruiz disposable keratome (now being marketed by LaserSight as the Automated Disposable Keratome [ADK])”

What was Dr. Casebeer’s connection to LaserSight when he presented the PMA to the FDA panel on July 22, 1999?  Doesn’t it seem likely that Dr. Casebeer had a financial interest in getting the VISX approval for LASIK in that it would create a huge need in the industry for microkeratomes?  Read from the LaserSight Technologies website under press releases.  This press release is dated 7/27/99 — just 5 days after Casebeer made the VISX LASIK presentation to the FDA Ophthalmic Devices Panel.

LASERSIGHT BEGINS SHIPMENT OF KERATOME BLADES

Winter Park, FL, (July 27, 1999) — LASERSIGHT INCORPORATED (Nasaq:LASE) announced today that it began shipment of its ULTRA EDGE™ Keratome Blades in the United States, Canada and other international markets. The shipment marks LASERSIGHT’s entry into the market for per- procedure laser vision correction products on a value-added basis to physicians and patients. The keratome is an instrument used to cut a thin corneal flap just prior to the LASIK procedure. These blades are the product of a joint venture between LASERSIGHT and Becton Dickinson, Inc. (NYSE: BDX). As previously announced, LASERSIGHT and Becton Dickinson Ophthalmic Systems entered into an exclusive agreement to develop, manufacture and distribute keratome blades. The market for laser vision correction is rapidly expanding, with the number of laser vision correction procedures in the United States expected to exceed 800,000 in 1999 and 1.2 million in 2000. Becton Dickinson Ophthalmic Systems is the worldwide leader in the manufacture and sales of surgical blades and ophthalmic cannula under the Beaver and Visitec brands. The keratome blades are automatically processed and manufactured utilizing surgical grade stainless steel. Becton Dickinson’s long history of manufacturing expertise should allow the venture to effectively respond to market demand for the product. Production is targeted to be in the range of 15,000 blades per month starting in August 1999. The Company will continue to closely monitor market demand and adjust production accordingly. The ULTRA EDGE™ Keratome Blades are manufactured utilizing a proprietary process and a material selected to yield a blade with superior cutting efficiency. Sharpness and cutting efficiency have been validated at the manufacturing source. Stephen A. Updegraff, M.D., a refractive surgeon practicing in St. Petersburg, FL, was one of a group of refractive surgeons who tested the keratome blades. Dr. Updegraff commented, “The blades represent a new standard of quality, and I am very impressed with the fact that they are manufactured from surgical grade stainless steel.” Michael R. Farris, chief executive officer of LASERSIGHT, commented, “The launch of the keratome blades is a key element of our business plan as it is consistent with our stated strategy of bringing to market new products that complement our existing laser technology. In addition, the product enables us to tap into a recurring revenue stream that will be generated from replacement sales of a single use product into an expanding and growing market.” Mr. Farris continued, “We are encouraged by the enthusiastic responses expressed by the surgeons who have used the product and believe our focus on quality and reliability will enable us to continue to gain market recognition. Going forward, we are uniquely positioned to meet the growing demand of this rapidly expanding market.” LASERSIGHT INCORPORATED provides quality technology solutions for laser refractive surgery and other innovative applications, mainly in the vision correction industry. The Company sells its products in more than 30 countries. In the United States, LASERSIGHT ‘s refractive scanning laser system has a pending pre-market approval application with the U.S. Food and Drug Administration and is not yet commercially available in this market. This press release contains forward-looking statements regarding future events and future performance of the Company, including statements with respect to anticipated sales revenue, which involves risks and uncertainties that could materially affect actual results. Investors should refer to documents that the Company files from time-to-time with the Securities and Exchange Commission for a description of certain factors that could cause the actual results to vary from current expectations and the forward looking statements contained in this press release. Such filings include, without limitation, the company’s Form 10-K, Form 10-Q and Form 8-K reports.

From the FDA website:

http://www.fda.gov/cder/present/dia698/diafda2/sld005.htm
http://www.fda.gov/cder/present/dia698/diafda2/sld007.htm
http://www.fda.gov/cder/present/dia698/diafda2/sld008.htm
http://www.fda.gov/cder/present/dia698/diafda2/sld009.htm

Shorts Have Dim View of Sunrise Technologies’ Success

“It’s unknown how the panel will react to the fact that nine of the 11 chief clinical investigators listed on its own Web site have purchased sizable stakes in Sunrise, which was brought to light by TSC.

I’m Not Just an Investigator, I’m Also an Investor:

Nine of 11 main investigators on Sunrise’s farsightedness laser have investments in the company.

Investigators Common shares granted*
David C. Brown 2,481,847
Donald R. Sanders 2,283,519
Alan B. Aker 1,948,109
Manus C. Kraff 1,003,931
Robert Gale Martin 677,840
Paul H. Ernest 77,353
Douglas G. Koch 13,500
Sandra C. Belmont 7,500
Peter J. McDonnell 5,000
*Beneficially owned. Source: Sunrise, SEC document of September 1998.

Coghlan sees no problem. “Does anyone really think that any of our clinical investigators, who are among the most respected names in ophthalmology, would do anything to hurt their reputations?” he asks.

Well, the FDA, for one, thinks it possible. In an overhaul of its policy on financial disclosure by clinical investigators, the agency wrote in March that it “has become increasingly aware of the existence of potentially problematic compensation arrangements between sponsors of FDA-regulated products and clinical investigators. … These arrangements clearly have the potential to bias the results of clinical studies.”

From http://www.thestreet.com/stocks/biotech/764869.html

New Disclosure Rules for Medical Investigators Won’t Apply to PR

Financial conflicts of interest involving clinical investigators of medical products are so common that starting in February the Food and Drug Administration will require all medical companies to disclose investments by investigators that are worth more than $50,000.

What won’t be required, however, is disclosure of the investments held by supposed experts quoted in company press releases.

Take the case of Sunrise Technologies (SNRS:Nasdaq – news), the maker of an eye laser to treat farsightedness. The company points out in a recent registration statement that more than half of its clinical investigators are also investors in the company. (That’s more than the norm, according to several industry observers, but at least it’s disclosed.)

However, unless you read the company’s Securities and Exchange Commission filings, you’d never know that Dr. Donald Sanders, who runs the Center for Clinical Research in Elmhurst, Ill., owns more than 5% of the firm. Sanders was quoted liberally in Sunrise’s recent press release announcing that it had filed an application for FDA approval of its laser. Quoted in the same release: Dr. Douglas Koch of Baylor College of Medicine, a clinical investigator who, according to the registration statement, is also a Sunrise investor.

Shift over to Staar Surgical (STAA:Nasdaq – news), which makes implantable contact lenses, and there’s Dr. Sanders being quoted again. (No mention that he’s a director of the company as well as an investor.)

And it’s all legit. All the FDA requires is that the comments be factual.

Neither officials from Staar nor Sunrise could be reached, but Sanders, whose firm consults on regulatory projects, sees nothing wrong with the lack of disclosure. Why? “It’s not standard practice, that’s why.”

From: http://www.thestreet.com/comment/herbonthestreet/185120.html

‘Bermuda cards’ allow off-label use of Visx laser

SOURCE

by Keith J. Croes
Executive Editor

An off-shore modification of Visx keycards allows U.S. surgeons to employ excimer laser treatments widely used elsewhere around the world.

A number of refractive surgeons in the United States are using Visx keycards that have been reprogrammed in Bermuda to override a software change ordered by the Food and Drug Administration a year ago, according to sources in private practice and industry.

At a rate of $40 per card, the Hamilton, Bermuda-based company, Technological Health Care Products (THCP) Ltd., “enhances” prepurchased Visx keycards meant for U.S.-sited lasers, a THCP official said. The card’s original “international” program, used extensively outside the United States, is thus restored and available for use on the U.S. machine.

Legal issues

An FDA official charges that the cards are “illegal,” which is probably technically correct, according to Wayne Matelski, an attorney who specializes in FDA regulations. “A component of a regulated device is a device itself, and the card is unapproved,” he said. The FDA would argue that [the cards] are illegal and would probably seize them if given the chance.”

The approved cards, which cost $260 each when purchased from Visx Inc., of Santa Clara, Calif., are hand-carried to Bermuda, or even sent by express mail, by laser center or practice representatives, not necessarily the surgeons themselves. Surgeons who use the reprogrammed cards point out their practice-of-medicine privilege to use an approved device for off-label applications.

“There is definitely a practice-of-medicine issue here,” Matelski said. “It would be up to the court to decide. A pro-government court might be expected to favor the FDA over the surgeon. However, a well-respected surgeon in a regional court might prevail.”

The reprogrammed cards allow the treatment of higher degrees of myopia and astigmatism than permitted by the approved labeling of the Visx laser. THCP believes that the company’s service violates no U.S. or Bermuda laws. “We do not market directly in the U.S., and word-of-mouth is the only way we market. U.S. doctors personally contact our office here for keycards,” said a THCP official, who declined to reveal his name. The FDA has not contacted the company, he said.

Numbers unavailable

The THCP official declined to reveal the number of cards the company has reprogrammed and the number of customers served. “The volumes have not been as large as we originally expected,” he said.

A U.S. laser center executive, whose operation includes three Visx lasers, acknowledged sending one shipment of about 800 cards to THCP for reprogramming. “We think this is the high road compared to custom lasers and gray-market lasers. These are approved lasers with proven software,” said the executive, who requested anonymity.

In a number of public statements, Morris D. Waxler, PhD, acting branch chief for the Diagnostic and Surgical Devices Branch of the FDA’s Center for Devices and Radiological Health, has called the cards “illegal.” Waxler pointed out that the agency recently outlined a regulatory pathway for surgeons who wish to apply for an investigational device exemption (IDE) for treating these patients.

“We are very sympathetic to the forces at work here, which is why we’ve developed a process so that surgeons who want to do these procedures can get an IDE or get into an established study,” Waxler said. “The surgeons who are using the cards are not contributing to the data collection and interpretation going on in order for us to understand what we’re doing to these patients.”

CRS-USA reaction

CRS-USA Inc. is pursuing one such IDE with a study coordinated by Guy Kezirian, MD, of SurgiVision Consultants, Inc., Scottsdale, Ariz. “The Bermuda cards raise concerns for patients and surgeons alike,” Kezirian said.

“Undergoing surgery with unvalidated technology that is obtained from an off-shore source leaves them with little recourse should a problem occur. The problem for surgeons is that they are left holding the entire bag for liability. Will their malpractice insurance cover them for activities the FDA says are illegal?”

With the recent approval of the Visx laser for low to moderate astigmatism, the demand for Bermuda cards will likely shrink, at least temporarily, industry sources predict. The pressure on the FDA to approve treatments for high myopia, however, is likely to grow.

Although Visx has heard reports of reprogrammed keycards, the company is not involved with the activity in any way, according to a Visx spokesperson. The THCP official also noted that THCP has no association with Visx.

FDA – Your Opinion?

SOURCE

“I hate the damn FDA. Its one thing for the laser makers to lie but it’s another thing to know that your life ended because the damn FDA was too ignorant, too careless, or too corrupt to want to do it’s job to stop them.”

SOURCE

“the FDA says they dont regulate the practice of medicine. but lying to the FDA in order to perpetrate fraud on the public is not medicine. therefore, it is regulated by the FDA.”

“the FDA says they dont regulate the practice of medicine. but lying to the FDA in order to perpetrate fraud on the public is not medicine. therefore, it is regulated by the FDA.”

“so the FDA can do something if its wants to. the question is whether the FDA itself is so corrupted by special interests that it doesnt want to. my guess is that it is. how else would research that was obviously deceptive make it through the opthalmic devices panel and be approved? if the fda took some kind of action, it might well have to admit to millions of consumers that they are facing long term damage to their vision. it could cause a lot of embarassment. so the fda is silent, just like almost everyone is silent.”

More FDA BIAS?

SOURCE (EyeWorld – August, 2006)

Inside the FDA: Reporting of medical device-related adverse events

by Malvina Eydelman, M.D. and also, an ophthalmologist. She is director of the Division of Ophthalmic and ENT Devices (DOED) in the Food and Drug Administration (FDA)/Center for Devices and Radiological Health (CDRH)/Office of Device Evaluation (ODE).

I have written several columns about how the Food and Drug Administration (FDA) regulates the routing of ophthalmic devices to market. FDA’s involvement in the medical devices, however, is not limited to the pre-market arena.

FDA monitors post-market reports of device-related adverse events/product problems (AEs). This is done to detect “signals” of potential public health safety issues, and it is an important aspect of FDA’s role.

Primary responsibility for this function is carried out by the Center’s Office of Surveillance and Biometrics. The interdisciplinary staff of clinicians and engineers that reviews these reports is headed by Tom Gross M.D., M.P.H. He provided his expertise in writing this column.

FDA’s ability to take appropriate and timely actions, where warranted, is inherently tied to its knowledge of the existence and the extent of a device-related problem shortly after it occurs. For this very important task FDA relies on the users of the devices (eye care practitioners in the case of ophthalmic devices).

Thus, it is of utmost importance that the ophthalmic community understands how, when, and where it should report potential problems. FDA relies on these reports to maintain safety surveillance of all FDA-regulated devices. Your reports may be the critical action that prompts a modification in use or design of the product, improves the safety profile of the device, and leads to increased patient safety.

Monitoring and understanding AEs

The FDA monitors post-market AEs through both voluntary and mandatory reporting. Voluntary reporting to the FDA began in 1973. It was not until 1984 that the FDA implemented mandatory reporting, per the Medical Device Reporting (MDR) regulation.

This regulation required device manufacturers and importers, as they still do today, to report device-related deaths, serious injuries, and malfunctions to the FDA. Additional legislative initiatives have resulted in significant changes to mandatory reporting. User facilities (hospitals, nursing homes, ambulatory surgical facilities, outpatient diagnostic and treatment facilities, ambulance services, and health care entities) are required to report deaths to the FDA and deaths and serious injuries to the manufacturer. These requirements are summarized below in Tables 1 and 2.

The FDA recently established a network of 350 user facilities (primarily hospitals) to enhance our understanding of AEs in the clinical environment in which they occur. This Medical Product Safety Network (MedSun) provides enhanced reports of AEs and a platform for discourse and resolution of important safety issues (e.g., via periodic audio conferences).1

To better understand reporting of AEs under the current MDR regulations governing mandatory reporting, I will define some of the key terms:

  • Serious injuries: Life-threatening events that result in permanent impairment of a body function or permanent damage to a body structure; events that require medical or surgical intervention to preclude permanent impairment or damage.
  • Malfunctions: Failure of a device to meet its performance specifications or otherwise perform as intended.
  • Device-related: The event was or may have been attributable to a medical device, or that a device was or may have been a factor in an event, including those occurring as a result of device failure, malfunction, improper or inadequate design, poor manufacture, inadequate labeling, or use error.

There are several guidances currently available about Medical Device Reporting (MDR) which can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/

topicindex/guidance.cfm?topic=224

Voluntary reporting

Voluntary reporting to FDA of device-related problems is a critical professional and public health responsibility. Currently, voluntary reporting takes place under MedWatch, a program created in 1993 to encourage voluntary reporting by all interested parties.2

MedWatch allows health care professionals and consumers to report serious problems that they suspect are associated with the medical devices they prescribe, dispense, or use. Reporting can be done on line at http://www.fda.gov/medwatch/getforms.htm, by phone (1-800-FDA-1088), or by submitting the MedWatch 3500 form by mail or fax.

Since its inception in 1973, the FDA’s database of voluntary and mandatory reports of device AEs has received approximately 1.5 million reports and currently averages about 180,000 per year. Mandatory reports account for close to 95% of the total.

The reports capture information on device specifics (e.g. brand name, model number), event description, pertinent dates (e.g. event date), and patient characteristics. Manufacturers also supply methods, results, and conclusion codes relevant to their report investigation.

The staff of clinicians and engineers review the individual reports from a variety of perspectives: the potential for device failure (e.g. poor design, manufacturing defect); use error (e.g. device misassembly, incorrect clinical use, misreading instructions); packaging error; support system failure; adverse environmental factors; underlying patient disease or co-morbid conditions; idiosyncratic patient reactions (e.g. allergy); maintenance error; and adverse device interaction (e.g., electromagnetic interference).

Several immediate actions, aside from routine requests for follow-up information, may be taken by the staff. These include:

Recommending directed inspections of manufacturers. These may lead to: (a) label changes, including those affecting device instructions or training materials, (b) product modification/recall, and (c) product seizure or injunction (rarely).

Recommending internal expert safety meetings. These may lead to public notifications, recommendations for additional post-market study, or meetings with the company to explore issues further.

Alerting regulatory authorities outside the United States through the international vigilance program (a program that allows for sharing AE information among regulatory authorities).

Other internal uses of the AE data are widespread and include: input into pre-market review (by providing human factor insights and information on product experience in the general population); input into recall classifications (involving a hazard evaluation based on AE data); monitoring of recalls (and assessing reports in similar products); input into product reclassifications and exemptions from pre-market notifications (based, in part, on a product’s safety profile); use in, and initiating of, standards efforts that establish device performance; educating the clinical community through newsletters, literature articles (peer-reviewed and professional and trade journals), and teleconferences; and as a general information resource for healthcare providers and the general public.

I hope that this column gives EyeWorld subscribers a strong appreciation of the importance of reporting medical device-related adverse events in support of FDA’s mission to protect public health. I look forward to thorough reporting by my ophthalmic colleagues.

References

1.www.medsun.net

2.Kessler DA. Introducing MeDWatch: A new approach to reporting medication and device adverse effects and product problems. JAMA 1993;269:2765-8.

Need To Contact The FDA?

GOOD LUCK! These wonderful people have helped me extensively ( NOT! ). If you’re expecting help, expect a runaround:

andrew.voneschenbach@fda.hhs.gov – 301-827-2410

Les Weinstein – OMBUDSMAN (CDRH) – les.weinstein@fda.hhs.gov – 301-827-7991

Christine Kellerman –SECRETARY (for Les Weinstein) (OA) – christine.kellerman@fda.hhs.gov – 301-827-7975

Matthew Tarosky – SR SUP REGULATORY O – matthew.tarosky@fda.hhs.gov – 240-276-0243

Linda S Kahan – DEPUTY DIRECTOR CDRH – linda.kahan@fda.hhs.gov – 301-827-7975

Everett Beers, Dr. – SUPV GENERAL ENGINEE – everette.beers@fda.hhs.gov – 301-594-2018 x136

Michael Marcarelli – SR SUP REGULAT O – michael.marcarelli@fda.hhs.gov – 240-276-0244

Viola Sellman – SUPV CONSUMER SAFETY OFCR – viola.sellman@fda.hhs.gov – 240-276-0125

Barbera Stellar – PUBLIC HEALTH ADVISOR – barbara.stellar@fda.hhs.gov – 240-276-3150 x144

Timothy Ulatowski – DIR OFFICE OF COMPLIANCE – timothy.ulatowski@fda.hhs.gov – 240-276-0100

Joy Lazaroff – SUPVY PARALEGAL SPECIALIST – joy.lazaroff@fda.hhs.gov – 301-827-7258

Ronald Swann – SUPV CONSUMER SAFETY OFCR – ronald.swann@fda.hhs.gov – 240-276-0115

Mark Weinstein – Assoc. Dep Dir CBER/OBRR – mark.weinstein@fda.hhs.gov – 301-827-3518

Gene Allen – PUBLIC HEALTH ADVISOR – gene.allen@fda.hhs.gov – 240-276-3150 x114

Malvina Eydelman – SUPV MEDICAL OFFICER  – malvina.eydelman@fda.hhs.gov – 301-594-2205 x132

Jean Toth-Allen – PHYSICIST – jean.toth-allen@fda.hhs.gov – 301-827-1585

Jerry Dennis – CONSUMER SAFETY OFFICER – jerome.dennis@fda.hhs.gov – 240-276-3330

Linda Lyons Drager (ODE) – SECRETARY (OA) – linda.lyons@fda.hhs.gov – 301-594-2186 x108

Pat Storer – CONSUMER SAFETY TECHNICIAN – patricia.storer@fda.hhs.gov – 301-594-2205 x184

Laurie Lenkel – REGULATORY COUNSEL – laurie.lenkel@fda.hhs.gov – 301-827-3390

Steven Kendall – SUPV CONSUM SAFETY OFFICE – steven.kendall@fda.hhs.gov – 301-594-1162

Susan Setterberg (phila) – REG FOOD AND DRUG DIR – susan.setterberg@fda.hhs.gov – 215-597-8058

Ed McDonald (phila) – CONSUMER SAFETY OFFICER – edward.mcdonald@fda.hhs.gov – 215-717-3739 x4524

Steven Kane (phila) – CONSUMER SAFETY OFFICER – steven.kane@fda.hhs.gov – 215-717-3718

Ronald Stokes (phila) – CONSUMER SAFETY OFFICER – ronald.stokes@fda.hhs.gov – 215-597-4390 x4533

No longer with the FDA or listed on employee directory:

Andrew VonEschenbach – ACTING COMMISSIONER OC

Lester Crawford

Mark McClellan

Ralph Rosenthal

Levering Keely –

Harold Pellerite –

ROBERT ZIMMERMAN (phila) – REGION SUPV –

DEBRA WOLF