FDA WARNING_LETTER - LASIK Vision Institute LLC - July 09, 2009

During a July 9, 2009, inspection, the FDA determined that Lasik Vision Institute, LLC, a medical device user facility in West Chester, Ohio, failed to comply with Medical Device Reporting (MDR) regulations (21 CFR Part 803). The facility uses ophthalmic lasers for LASIK procedures, which are medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

The inspection revealed that the LASIK devices are misbranded under section 502(t)(2) of the Act because the firm failed to furnish required material or information per section 519 of the Act and 21 CFR Part 803. A significant deviation identified 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 prevent regulatory actions such as seizure, injunction, and/or civil money penalties. The firm must respond in writing within fifteen working days, detailing specific corrective steps, preventative measures, and a timetable for implementation, including documentation. The letter emphasizes that this is not an exhaustive list of violations and the firm is responsible for overall compliance.