FDA WARNING_LETTER - LCA Vision Inc/Lasik Plus Vision Center - August 05, 2009

The FDA issued a Warning Letter to LCA Vision Inc. and LasikPlus Vision Center-Cincinnati following an inspection from June to August 2009. The firm was identified as a medical device user facility, subject to Medical Device Reporting (MDR) regulations (21 CFR Part 803) for its ophthalmic LASIK lasers. The inspection revealed non-conformance with MDR regulations. Specifically, the LASIK devices were deemed misbranded under section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act because the firm failed to furnish material or information required by section 519 of the Act and 21 CFR Part 803. A significant deviation noted was the failure to develop, maintain, and implement written MDR procedures, as mandated by 21 CFR 803.17. Although no Form FDA 483 was issued, these violations were discussed with management. The FDA requires prompt corrective action, with a written response due within fifteen working days detailing specific steps taken, prevention plans, and documentation, including a timetable for ongoing corrections. Failure to comply may lead to regulatory actions such as seizure, injunction, or civil money penalties, and could impact future federal contracts. The letter emphasizes that this is not an exhaustive list of violations, and the firm is responsible for ensuring overall compliance with all applicable FDA laws and regulations.