The U. S. Food and Drug Administration issued warning letters to 17 Lasik vision-correction ambulatory surgical centers after inadequate reporting systems were found during an inspection.
The inspections did not find problems with the use of Lasik devices at the centers as per the FDA.
Dr. Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health said, "Ambulatory surgical centers that perform Lasik must maintain a robust reporting system as required by law. 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. reported that six of its centers were inspected by the FDA in the past four months. One center required additional written procedures, as outlined in a letter TLC received from the FDA on Aug. 20.
President and Chief Executive James Tiffany informed that the company responded soon after and said, "Neither the inspection nor the observations from the inspection related to device safety or efficacy of the Lasik procedure".
The laser-vision correction procedures have slumped for more than a year due to recession following which the news was released. The work is not covered usually by health insurance.












