FDA Petitioned to Inspect and Sanction LASIK Facilities on MDRs

Reprinted with permission from fdaweb.com

Days after FDA principal deputy commissioner Joshua Sharfstein launched an investigation into mounting complaints by injured LASIK vision-correction patients, one of them 5/25 filed a citizen’s petition asking for sanctions against LASIK clinics that have not reported adverse events as required under the medical device reporting (MDR) regulation. The petitioner, former Long Island (NY) restauranteur and LASIK patient advocate Scott A. Tolchin, also asked the agency to inspect clinics and to “ensure” their compliance with FDA’s user facility reporting regulation. Tolchin told FDA Webview he has been on disability for a year due in part to his LASIK-related problems which worsened since his 1997 surgery.

“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,” Tolchin’s liberally documented petition says. “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 petition criticizes FDA’s “collaboration” last year with the American Society of Cataract and Refractive Surgery to study post-LASIK quality of life. At the time, the society said there had been only 140 dissatisfied comments from patients in the preceding 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,” the petition says.

Tolchin says injured patients expressed “harsh criticism” of the “unprecedented partnership with LASIK professional groups” when they testified at a 4/25/08 Ophthalmic Devices Panel meeting where a moratorium on the surgical procedure was requested. “Injured patients believe that LASIK surgeons are biased and lack objectivity,” his petition says, “and that the proposed study amounts to the FDA putting the fox in charge of guarding the hen house.”

Other issues raised in the petition include alleged multiple reuse by surgeons of single-use microkeratome blades that cut a flap in the cornea prior to the LASIK procedure, a reported four-fold increase in post-LASIK suicides, and a surge in adverse reports from patients and family members after publicity about the 4/25/08 panel meeting, to 500 in a single year. The petition alleges that despite an FDA requirement that all prospective LASIK patients receive a Patient Information Booklet, LASIK surgeons commonly fail to do this.

“A meta-analysis of Summaries of Safety and Effectiveness for the 12 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 eye which are worse than before surgery, much worse than before surgery, moderately severe or severe,” the petition says. Since the first LASIK device approval in 1998, about 8 million American have undergone the surgery, it says.

On 5/22, CDRH director of compliance Timothy A. Ulatowski sent a letter to eye care professionals cautioning them against deceptive or misleading claims and providing sources of additional information about intended uses and adverse effects.