FDA Sends Warnings To 17 Lasik Centers For Subpar Reporting

The U.S. Food and Drug Administration has issued warning letters to 17 Lasik vision-correction ambulatory surgical centers after inspections found inadequate reporting systems.

The inspections didn't find problems with the use of Lasik devices at the centers, the FDA said.

"Ambulatory surgical centers that perform LASIK must maintain a robust reporting system as required by law," said Jeffrey Shuren, MD,  acting director of the FDA's Center for Devices and Radiological Health. "Reporting adverse events to the FDA is critical to better understand the safety and effectiveness of ophthalmic lasers used in LASIK procedures and to enable the FDA to take appropriate actions where the lasers do not meet safety and effectiveness requirements."

TLC Vision Corp. (TLCV) issued a release Thursday night, saying six of its centers were inspected by the FDA in the past four months. One center was found to need additional written procedures, as outlined in a letter TLC received from the FDA on Aug. 20.
President and chief executive, James Tiffany, said the company responded soon thereafter, adding that, "Neither the inspection nor the observations from the inspection related to device safety or efficacy of the LASIK procedure."