Reprinted with permission from fdaweb.com
17 Warning Letters Target MDR Reporting at LASIK Sites
FDA says it has issued Warning Letters to 17 LASIK ambulatory surgical centers after recent inspections revealed that they had inadequate systems for reporting adverse events related to the vision correction surgery. FDA has recently ramped up its enforcement efforts, and CDRH compliance director Timothy Ulatowski publicly predicted that this week will be a “Warning Letter Event.” The agency says additional inspections of ambulatory surgical centers are pending.
The inspections presumably were in response to growing criticism of FDA’s oversight of the LASIK usage and mounting complaints by injured LASIK vision-correction patients. One such patient filed a citizen petition earlier this year (see story) just days after FDA principal deputy commissioner Joshua Sharfstein launched an investigation into the complaints. The petition seeks 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) restaurateur 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.
The 17 Warning Letters, which were issued 10/9, did not identify problems with the devices themselves, and will be posted 10/20 along with other FDA Warning Letters routinely released each week. FDA Webview has obtained two templates of the Warning Letters — one for those that received an FDA-483 and one for those that did not. Each letter cites a firm for failing “to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17.”
Additionally, in order to get a better handle on LASIK-related injuries, FDA says it has begun a “collaborative study with the National Eye Institute and the U.S. Department of Defense to examine the potential impact on quality of life…” The project’s goals are to determine the percentage of patients with significant quality of life problems after having vision-correction surgery and to identify predictors of these problems.
The project, which will run until the end of 2012, will consist of three phases:
Phase 1, which began in July, is to design and implement a Web-based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK
Phase 2 will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center
Phase 3 will involve a national clinical trial and will study the impact of the procedure on quality of life following LASIK in the general population.
“The results of the project will help identify factors that can affect quality of life following LASIK and potentially reduce the risk of adverse effects that can impact the surgical outcome,” FDA says. “If any of these factors are related to the safety or effectiveness of the lasers used in LASIK surgery, the FDA will evaluate whether any action is necessary.”
Injured LASIK patient and activist Paula Cofer was skeptical about FDA’s quality-of-life study with the Defense Department. In a comment to FDA Webview, she said:
“In my opinion, the Department of Defense has demonstrated bias in favor of LASIK. For example, Dr. Steven Schallhorn who directed the largest refractive surgery program within the Department of Defense until his recent retirement, is a paid medical malpractice defense expert witness, has made public statements and published literature denying connection between a poor LASIK outcome and diminished quality of life, and is currently medical director of one of the largest corporate providers of LASIK in the world. Schallhorn co-authored studies favorable to LASIK with current Department of Defense LASIK surgeons.
“Several Department of Defense LASIK surgeons testified in favor of LASIK at an FDA hearing in April 2008.
“Furthermore, I feel that FDA’s earlier partnership with organized ophthalmology was inappropriate, and that the planned prospective quality of life after LASIK study is simply a strategy to stall for several more years while refractive surgeons either upgrade existing technology or prepare to market alternative technologies for refractive surgery.”