FDA WARNING_LETTER - Lasik Plus Vision Center - July 09, 2009

An FDA inspection of LasikPlus Vision Center in Concord, California, on July 9, 2009, determined the facility is 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 the facility was not in conformance with MDR regulations, and a Form FDA 483 was issued. The LASIK devices are considered misbranded under section 502(t)(2) of the Act because the firm failed to furnish required information under section 519 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 these violations. The firm must notify the FDA in writing within fifteen working days, detailing specific steps taken, how similar violations will be prevented, and providing documentation and a timetable for corrections. Failure to comply may result in regulatory actions such as seizure, injunction, and civil money penalties, and could impact federal contracts. This letter is not an exhaustive list of violations, and the firm is responsible for ensuring overall compliance.