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:

            A. 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

            B. 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)

            C. 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]
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
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

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.