FDA WARNING_LETTER - Lasik Laser - November 02, 2009

On November 2, 2009, an FDA inspection of Saint Vincent Surgery Center in Erie, Pennsylvania, identified that the facility, a medical device user facility, was not in conformance with Medical Device Reporting (MDR) regulations (21 CFR Part 803). The ophthalmic laser used for LASIK procedures at the facility is a medical device subject to these regulations.

The inspection revealed that the LASIK devices are misbranded under section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(t)(2)) because the firm failed to furnish required material or information per section 519 of the Act (21 U.S.C. 360i) and 21 CFR Part 803. A significant deviation noted was the failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. Although no FDA Form 483 was issued, these violations were discussed with management.

The FDA requires prompt corrective action to address the violation. Failure to comply may result in regulatory actions including seizure, injunction, and/or civil money penalties, and may impact the award of federal contracts. The facility must notify the FDA in writing within fifteen working days of receiving the letter, detailing specific corrective steps, how recurrence will be prevented, and a timetable for implementation if