APR 3, 2012

WARNING LETTER

VIA UNITED PARCEL SERVICE

Ms. Casi Cleaveland
Regional Director
LasikPlus Vision Center
200 Galleria Parkway
Suite 200
Atlanta, Georgia 30339

Dear Ms. Cleaveland:

During an inspection of your firm located in Atlanta, Georgia, on October 5-6, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a medical device user facility that is subject to the statutory requirements of the Medical Device Reporting (MDR) regulation, found at Title 21 Code of Federal Regulations (CFR) Part 803.

The ophthalmic laser used at your facility to perform Laser-Assisted In Situ Keratomileusis (LASIK) procedures is a medical device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or function of the body.

Our inspection revealed that your facility’s device is misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting. Significant violations include, but are not limited to, the following:

Failure to submit a FDA Form 3500A or an electronic equivalent to the device manufacturer within ten working days of becoming aware of information that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of your facility, as required by 21 CFR 803.30(a)(2). For example, the Customer Incident and Event Reporting Form dated April 21, 2011, for (b)(6), indicated that an EDIR surgery was conducted to remove debris from a patient without detailing the reason for the procedure and the facility’s rationale for considering the event to be not reportable.

The information included for (b)(6) suggests that, after the LASIK procedure, the patient lost more than 2 lines of best corrected visual acuity (BCVA). FDA believes that the loss of 2 lines of BCVA represents an impairment of vision function. Therefore, the information included for (b)(6) meets the definition of a serious injury found at 21 CFR 803.3, which should have been reported by your facility to the device manufacturer. There is no evidence that the complaint was forwarded to the manufacturer.

We reviewed your facility’s response and conclude that it is not adequate. The response states that your facility does not consider adverse events as reportable when the event is not the result of laser equipment, but rather the patient’s response to post-operative care. Your facility should be aware that 21 CFR 803.3 states that, if a medical device may have been a factor in a serious injury, then such event meets the criteria for reportability.

Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.

Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Surveillance and Biometrics, MDR Policy Branch, White Oak Building 66, 10903 New Hampshire Avenue, Room 3208, Silver Spring, MD 20993. Refer to the Unique Identification Number #255515 when replying. If you have any questions about the contents of this letter or wish to discuss MDR reportability criteria or schedule further communications, please contact: MDR Policy Branch at (301) 796-6670 or by email at MDRPolicy@fda.hhs.gov.

If your facility wishes to submit MDR reports via electronic submission, it can follow the directions stated at the following URL: http://www.fda.gov/MedicalDevices/deviceregulationandguidance/guidancedocuments/ucm094529.htm#where1

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.

Sincerely yours,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health

Accessed online 4/18/2012 at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm300497.htm

Reprinted with permission from www.fdaweb.com
03/09/2012

David Muller, who as founder and CEO of Summit Technology gained in 1996 the first excimer laser approval for the controversial LASIK vision correction surgical procedure, announced 3/8 the submission of an NDA for VibeX (riboflavin ophthalmic solution)/KXL System to be used in treating corneal damage often associated with LASIK. The announcement came from his new company Waltham, MA-based Avedro Inc., which Muller formed with venture capital backing in 2007 after Summit was acquired by Alcon.

The new NDA seeks an indication for the treatment of keratoconus (a naturally occurring disease in which the cornea distends in a cone shape) and corneal ectasia following refractive surgery (LASIK). Morris Waxler, the CDRH branch chief who led the approval of Muller’s device in 1996 and others like it, is now aggressively seeking the removal of their LASIK indication based on a higher permanent injury rate from the LASIK procedure than disclosed by the sponsors in their data submissions.

Avedro’s news release quoted Cornea and Laser Eye Institute medical monitor and director Peter Hersh as saying that the “ophthalmology community is now looking forward to the possibility of offering cross-linking to keratoconus and corneal ectasia patients in the near future, addressing a significant unmet medical need. Currently, there are limited treatment options for decreasing the natural progression of keratoconus and ectasia. Cross-linking has the promise of stabilizing these progressive corneal disorders and maintaining patients’ visual function over time.”

Corneal collagen cross-linking with riboflavin and ultraviolet light is described by the National Keratoconus Foundation as a process that increases natural collagen crosslinks in the cornea, thus strengthening it and preventing it from further bulging out. The treatment’s possible extension to treat post-LASIK ectasia was recognized by FDA last year as deserving of orphan drug designation, offering seven years market exclusivity. Avedro’s news release said the VibeX/KXL System for corneal collagen cross-linking received the European CE Mark in 2010 and has been commercially available internationally since then.

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Related:

Watch video of an American Investigator report concerning David Muller, Summit Technology, and the scandal surrounding FDA leak of competitor’s, VISX Inc., documents. Watch

Read Jim Dickinson’s March 1999 article on the 1995 VISX Inc. document leak to rival Summit Technology’s then-President, David Muller: [Capitol] Hill closes file on device secrets leak: ex-reviewer did it. Read article

December 31, 2011

On 12/27/2011, the LASIK industry watchdog group, LASIK Surgery Watch (LSW), sent a letter to the FDA’s Center for Devices and Radiological Health requesting “that the FDA take immediate action to stop deceptive and misleading advertising of LASIK by Kim Robbins, M.D.”

The letter, addressed to Steven Silverman, Director of the Office of Compliance, alleged false and misleading advertising of LASIK on the Robbins Eye Center website.

Attached to the letter was a 34-page “Consent Order” issued 11/22/2011 by the Connecticut Department of Health citing Robbins Eye Center for “wrong eye surgery, inadequate sanitation in the operating room, inadequate medical follow-up and monitoring after surgery, and questionable credentials of medical staff.”

Read letter with attached consent order

Reprinted with permission from www.fdaweb.com
09/28/2011
FDA Warns Against Illegal LASIK Ads — Again

Despite a 5/22/09 letter to eye care professionals cautioning against inappropriate advertising and promotion of FDA-approved lasers used in refractive procedures such as LASIK, FDA says it continues to receive information concerning improper promotion and advertising practices by eye care professionals. So it is writing to them again.

In a 9/23 letter, FDA says it wants to “emphasize the importance of providing adequate risk information in [your] advertising and promotion of FDA-approved lasers used in refractive procedures, and to advise these professionals where to get additional information, if needed.”

FDA says it expects that the notice and information about FDA resources on approved lasers and their associated risks will be sufficient to enable eye care professionals to correct within 90 days any ads or promotional materials that don’t comply with the Federal Food, Drug, and Cosmetic Act. “After that time,” it warns, “FDA may take regulatory action against eye care professionals whose advertisements or promotional materials violate the FD&C Act. Agency actions may include Warning Letters, product seizures, injunctions, and civil money penalty proceedings.”

The letter notes that it is critical that eye care professionals disclose risk information appropriately and effectively to consumers in all advertisements and promotional materials concerning restricted devices, including the consequences that may result from the device’s use. “FDA believes that eliminating false or misleading health-related advertising, as well as false or misleading product labeling, is an important part of protecting the public health,” it concludes.

August 16, 2011
Reprinted with permission from www.fdaweb.com

LASIK Patients Ask Hamburg’s Help on Deferred Petition 08/16/2011

While CDRH defers a decision on a petition from former staffer Morris Waxler to withdraw the LASIK indication from ophthalmic laser approvals, injured LASIK patients yesterday sent commissioner Margaret Hamburg a 504-signatory petition in support and asking her to “carefully consider each signer’s remarks.”

Typical of such remarks were:

Eileen Newell, CA: “This issue is VERY important to me as I am one of the 20% of people with disastrous Lasik results. I have extremely dry eyes, starbursts, double vision, and severe depression. I can’t see my husband across from me at 12 feet or so. Can’t drive safely night or day. I am sick that I was misled regarding the chances of something like this happening.”

Vandana Gupta, India: “Because my life has changed forever. And because I have to start it afresh. And that is not easy.”

Robert Owen, United Kingdom: “Am now left with huge floaters constantly in my vision as a result of LASIK; a totally unnecessary practice.”

Janis Morrow, TX: “We came way too close to risk destroying our daughter’s eyes with this procedure. I pray they recall the lasik devices and outlaw the procedure.”

Zoltan Zeisky, PA: “I had LASIK, and I wish I could turn back the clock to undo my life altering MISTAKE!!”

Name not displayed, MO: “My brother has been practically blinded by LASIK surgery. He lives in chronic pain.”

Similar anecdotal testimony, although fewer in number, was given by injured LASIK patients at an April 25, 2008 meeting of the Ophthalmic Devices Panel of FDA’s Medical Devices Advisory Committee.

After hearing it all, panel chair Jayne Weiss, ophthalmology professor at Detroit’s Kresge Eye Institute faulted the industry for its “aggressive marketing” but wimped out by suggesting it was something for the Federal Trade Commission to look into. Subsequent efforts to interest that agency in LASIK vendors’ promotional violations produced nothing.

Reprinted with permission from www.fdaweb.com
2/1/2011

Twenty months after CDRH’s then director of compliance, Timothy Ulatowski, cautioned the nation’s eye care professionals not to make misleading or unsubstantiated claims in their advertisements about the effectiveness of lasers used in LASIK surgery, the Center has conducted no follow-up and last week announced it has no jurisdiction over LASIK ads.

“These lasers,” wrote Ulatowski back then, “are restricted medical devices that have been approved for particular uses and have risks associated with their use. Advertising and promotional materials for FDA-approved lasers used during LASIK procedures must be truthful, properly substantiated and not misleading.

“A restricted device is misbranded under the Federal, Food, Drug, and Cosmetic Act (Act) if its advertising is false or misleading (21 USC 352(q)). In determining whether the advertisement is misleading, the FDA takes into account not only representations made or suggested by statement, word, or design, but also the extent to which the advertisement fails to reveal facts material in the light of such representations, or material with respect to consequences which may result from the use of the device to which the advertisement relates under the conditions of use prescribed in the advertisement (21 USC 321(n)).”

Fast-forward 20 months to last Friday (1/28), when CDRH ombudsman David S. Buckles told LASIK victim and activist Paula Cofer: “I’ve investigated the matter you raised regarding the advertising practices cited in your message. Because the advertising practices apparently do not relate to medical products per se, but rather are advertising for the provision of services, we do not have jurisdiction in this matter. My understanding is that these issues are handled as ‘service industry claims’ by the Federal Trade Commission.”

Cofer, an FDA advisory panel patient representative, had sent CDRH compliance director Steven Silverman what she called a “blatantly deceptive” Web site link by Florida-based Brandon Eye Associates, and Silverman passed her off to Buckles, who has no enforcement authority.

In her request to Silverman, Cofer wrote that the Web site’s front page banner headline, “Kiss Your Contacts and Glasses Goodbye is misleading and deceptive. There is no disclaimer that some patients may need to continue wearing glasses or contact lenses, and there is no mention of risks, side effects, and contraindications.

“This is an example of the typical hype and failure to disclose risks that is prevalent in LASIK advertising on the Internet,” Cofer’s email to Silverman went on. “We, the injured LASIK patient community, have complained about this for years, but I have seen no change in the way LASIK is advertised. Former director of compliance, Timothy Ulatowski, sent a letter on 5/22/2009 to eye care professionals in what appeared to be a crack down on false and misleading LASIK ads. Since that time, it’s only gotten worse. There are thousands of LASIK ad violators on the Internet.

“As injured LASIK patients, what should we do when we see this type of illegal ad? Will anything be done by the FDA if we take the time to report them?

“I await a response.”

Another victim and activist, Dean Kantis, says he has sent CDRH “hundreds” of violative LASIK ads, to no effect. Has FDA investigated any of them, and if so, with what result? Buckles says “we are not in a position to disclose the status or even the existence of compliance and enforcement actions that are being contemplated or are in progress.”

Meanwhile, nearly 300 people have signed an online forum supporting a petition filed earlier this month by former CDRH ophthalmic devices director Morris Waxler, seeking an immediate ban on the procedure because of its unacceptable adverse events rate.

FDA did not respond to two requests for its input on this report.

Reprinted with permission from www.fdaweb.com

02/01/2011

Direct from FDA’s “egg on our face” department comes the confession of press officer Karen Riley that she mislaid the answer to our request for clarification about the agency’s jurisdiction/no jurisdiction over “restricted” device advertising, thus missing our deadline. Our story, CDRH Disowns Statutory Authority Over LASIK Ads, attempted to reconcile a 20-month-old CDRH letter to eye care professionals asserting FDA jurisdiction over their LASIK ads with a 1/29 statement that FDA has no jurisdiction because the Federal Trade Commission has that jurisdiction.

Unstated in either letter was this new information, at the bottom of Riley’s seven-line delayed response to our request for clarification: “If statements in advertising and promotional materials do not relate to any of these restricted devices (or other FDA-regulated product), FDA generally defers oversight of such advertising and promotion to the FTC which has authority over unfair and deceptive business practices, including false advertisements related to products and services.”

If injured LASIK patients had known this 20 months ago, they could have sent all their LASIK ad complaints to FTC rather than to CDRH — which apparently ignored them.

01/24/2011
Reprinted with permission from www.fdaweb.com

As FDA continues to dither in the face of new data challenging the safety of vision-enhancing LASIK eye surgery, a new report to be published next week by the German technology innovator BioShape Holding will support an immediate ban on the procedure. Adding to data in a petition for an immediate ban from former CDRH LASIK review chief Morris Waxler, the company says it has developed a unique device that measures the topography of the eye during refractive laser treatment and its research has shown “that LASIK in general is too dangerous to be allowed,” according to co-founder Daniel Kluting in an email to FDA Webview.

“The problem is that the LASIK cut brings problems to the structure of the eyes,” Kluting writes. “Because we have the only measuring device that is able to measure the topometry of the eyes with resolution of a few microns, we can look deeper into microeffects than anybody else. One of the major questions in research is, what is the cornea built of? From our research it seems to be that it consists of tissue layers with a tensive strain to all sides. Think about cutting in something like that!”

The permanence of the never-healing corneal flap cut is a major concern in Waxler’s petition, which last week was still deep in a queue in the Commissioner’s Office, awaiting a decision on whether or not to even accept it for consideration. In less than a year, Waxler has hardened his position from tolerating LASIK’s continuation to petitioning the agency for a complete ban and vowing to seek FDA Office of Criminal Investigations focus on laser makers who allegedly hid LASIK safety issues.

Moreover, it has been 16 silent months since former CDRH compliance director Tim Ulatowski launched a mini-blizzard of Warning Letters to LASIK ambulatory surgical facilities over their failure to file MDR reports and peppered the industry with advice to include risk information in their ads — with no further word from him or his successor, Steve Silverman, about agency follow-through, if any.

During the ensuing inactivity, injured LASIK victim and activist Dean Kantis says he has sent the agency “hundreds” of violative LASIK ads “that do not list all known risks and side effects … And the FDA continues to do NOTHING to discipline them. Why is it when I turn on the TV, every prescription drug commercial has 30 seconds of warnings yet when it comes to elective LASIK ads on TV or radio, there isn’t one word mentioned of the warnings?”

FDA’s ingrained unresponsiveness on the LASIK safety issue may be well illustrated by its failure to respond to a cogent 9/13/09, heavily documented 14-page letter from LASIK Surgery Watch to CDRH director Jeff Shuren describing the risks of the procedure and contending that “FDA has been grossly negligent and has placed patients’ interests secondary to interests of surgeons and medical device manufacturers.” The organization said 1/23 that none of its letters to the agency had brought responses.

Kluting’s email says that “from our point of view we would like to see LASIK stopped immediately. Then the laser manufacturers need to do some basic research on eyes [to] probably come up with a completely new way how to do refractive surgery. During the last 7 years the laser industry knew the problems, but did not want to go through the process of basic research combined with the [stopping] of LASIK. Right now with LASIK the cornea is damaged, the only good thing is that the cornea excuses a lot and the eye is still able to see. Nearly all risks of LASIK are because the procedure is not safe. It’s not because of the patient or a misfortune.

“We have just a measuring device. Our goal was to measure the ablation during refractive surgery to avoid using nomograms and be more precise. We did clinical trials with one of the large players on the market. But we found out that first all surgeons and the industry need to understand the eye better. We have a couple of ideas how refractive surgery can be in the future, but till now … laser manufacturers avoid … [talking] with us. Even those we made the clinical trials with, 8 years ago. It’s easier to leave the moneymaking machine LASIK turned on than to go through the struggle of development.

“So we went into the market of scleral lenses and wait for the refractive market to wake up. All patients who got hurt by LASIK since mid-2005 could have been prevented.”

BioShape’s new report next week is expected to update and supersede its 2005 report on the same subject, Complications of Refractive Laser Surgery.

In a comment to FDA Webview, former FDA medical device compliance director Larry R. Pilot, who has been deeply involved in the LASIK issue with injured patients, called FDA’s management of its regulatory program for LASIK “a clear dereliction of duty and responsibility to the concept of ‘protection of the public health’.

While there may be valid applications for LASIK eye surgery,” Pilot continued, “the vast majority of uses involve risks to the patient/customer that are often unknown until after the fact. The FDA/CDRH has failed incredibly to monitor post market experience through its mandatory MDR program. For just this program alone, the potential for patient protection was there for years, yet the CDRH deliberately ignored the responsibility to inspect or review the performance of any of the possible thousands of user facilities which were in absolute violation of law and regulation.

“Current and past FDA/CDRH employees shared this liability and should have been/should be punished for their failures. … I agree that the optimal approach to reporting is to have the FDA/CDRH enforce the MDR requirement applicable to user facilities. From the outset of my involvement with this LASIK issue, I have repeatedly emphasized this fact. It took two years for the FDA to display some movement, but more is needed.”

Asked to comment on this story, FDA press officer Karen Riley replied: “We cannot comment on the specifics of the German report, as we have not received or reviewed it. As you well know, FDA continues to monitor the safety and effectiveness of all devices, including the lasers approved for LASIK. In October of last year we provided a brief update on our role in a three-part study of LASIK that is still in the beginning phases. It is a project that we hope will yield additional insights about this procedure. Stay tuned.”

Reprinted with permission from www.fdaweb.com
01/06/2011

Former CDRH branch chief for diagnostic and surgical devices Morris Waxler, who has publicly said the agency “screwed up” when it approved LASIK vision enhancement lasers on his watch in 1997, petitioned the agency 1/6 to undo that mistake by “withdraw[ing] FDA approval (PMA) for all LASIK devices and issue a Public Health Advisory with a voluntary recall of LASIK devices in an effort to stop the epidemic of permanent eye injury caused by lasers and microkeratomes used for LASIK eye surgery.” CDRH is currently awaiting the results of a U.S. Navy LASIK quality-of-life study it commissioned in 2009 that is expected to report at the end of 2012.

In his extensively documented petition, Waxler says the approval was based on data that were “dominated by LASIK surgeons working hand-in-glove with LASIK manufacturers. Data recently brought to light exposes this partnership for what it was: a classic example of the fox guarding the henhouse, wherein the primary arbiters of safety and effectiveness of LASIK devices were the device manufacturers and its collaborators.

“Surgeons used LASIK devices in violation of required manufacturing quality controls (21 CFR 820), patient protections (including but not limited to 21 CFR 50; 54; 56; and 812), and reports of adverse events (including but not limited to 21 CFR 803; 812; and 820) when they manufactured and distributed LASIK devices in interstate commerce within the United States as:

• Homemade lasers (‘black boxes’)
• Imported investigational lasers (‘grey boxes’)
• Illegal key cards (“Bermuda cards”) and
• ‘Off-label’ photorefractive keratectomy (PRK) lasers

“As a consequence,” Waxler’s petition continues, “the FDA was deprived of knowledge of the full extent of LASIK injuries prior to and during FDA reviews of documents submitted in support of the safety and effectiveness of LASIK devices under 21 CFR 812 and 21 CFR 814.

“In addition, LASIK manufacturers and their collaborators withheld safety and effectiveness information from their investigational device exemption (IDE) reports to the FDA. In addition, they hid LASIK injuries from FDA within the context of out-of-court settlement of innumerable lawsuits. Clinic-sponsored IDE studies cherry-picked, withheld, and hid data from FDA that clearly showed LASIK with excessive adverse event rates (greater than 1%). These activities were an industry-wide effort, organized wholly or in part by the manufacturers and their collaborators in order to circumvent FDA law and regulation. I will submit CONFIDENTIAL information on these matters separately to FDA’s Office of Criminal Investigation.”

Waxler petition says that contrary to FDA’s own device approval standard limiting adverse events to 1%, published scientific data show that LASIK devices induce an average adverse event rate of about 22% “that persists beyond six months to five or more years.”

Moreover, he says, the published data shows that LASIK devices transform healthy corneas into sick corneas that never completely heal; are permanently weakened, vulnerable to trauma and inflammation; cause neuropathic dry eyes, have pathology that progresses annually; are vulnerable to blinding corneal bulging (keratectasia); compromise night vision; have unstable vision corrections that regress; and require eye care that otherwise would not be needed.

“FDA originally counted glare, halos, dry eye, night driving difficulties, and similar problems after excimer laser refractive surgery as adverse events,” Waxler’s petition says, citing the FDA-approved Patient Information Brochure where it says “…adverse events beyond the first few months: night vision difficulty (48.1% at six months)…glare (34.4% at 6 months)…”

Waxler says LASIK manufacturers and their collaborators successfully pressured FDA to classify these problems as mere “symptoms” so that manufacturers could claim that the adverse event rate is less than 1%. “The true adverse event rate six months or more post-LASIK is at least 20 times the FDA approvable rate of 1%,” he says.

Waxler’s petition includes a table showing, he says, that “manufacturers knew that about 43% of LASIK patients’ visual acuity could be improved by wearing spectacles 6-12 months after surgery. The manufacturers and their collaborators distorted this evidence.”