FDA WARNING_LETTER - Lasik Vision Institute (Boca Raton, FL) - January 11, 2009

On January 11, 2009, an FDA inspection of Lasik Vision Institute in Boca Raton, Florida, identified the facility as a medical device user facility subject to Medical Device Reporting (MDR) regulations (21 CFR Part 803). The ophthalmic laser used for LASIK procedures is a medical device. The inspection revealed non-conformance with MDR regulations, resulting in a Form FDA 483.

The LASIK devices are considered 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 provide required information under 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.

The FDA requires prompt corrective action to address this violation. Failure to comply may lead to regulatory actions such as seizure, injunction, and/or civil money penalties, and may impact future government contracts. Lasik Vision Institute must respond in writing within fifteen working days, detailing specific corrective steps, prevention plans, and a timetable for implementation, including documentation. The response should be sent to Ronald Swann, Branch Chief, Dental, ENT, and