FDA WARNING_LETTER - Rand Eye Institute

The FDA issued a Warning Letter to William J. Rand, M.D., Medical Director and Founder of Rand Eye Institute, for promoting the VISX Star S4 Laser on its website in violation of the Federal Food, Drug, and Cosmetic Act (the Act). The VISX Star S4 Laser is a restricted device used in refractive procedures like LASIK.

The Rand Eye Institute's website misbrands the device under sections 502(a) and (q) of the Act because its advertising is false or misleading. Specifically, the website promotes the benefits of the VISX WavePrint System and the VISX S4 IR laser, including features like Variable Spot Scanning and 3D ActiveTrak, and highlights positive patient outcomes. However, it fails to disclose material facts, including relevant risk information such as contraindications, warnings, precautions, and adverse events associated with the VISX Star S4 IR Laser. Common risks include dry eye syndrome, potential need for glasses/contacts post-surgery, debilitating visual symptoms (halos, glare, starbursts, double vision), and vision loss.

The FDA requires the Rand Eye Institute to immediately cease promoting the VISX Star S4 Laser in violation of the Act and take prompt action to correct these violations. Failure to comply may result in regulatory actions including seizure, injunction, and civil money penalties. The firm must notify the FDA in writing within fifteen business days of the specific steps taken to correct the violations, how similar violations