FDA WARNING_LETTER - Pacific Vision Institute

The FDA issued a Warning Letter to Pacific Vision Institute on August 14, 2014, for promoting the WaveLight EX500 Excimer Laser System on its website in violation of the Federal Food, Drug, and Cosmetic Act. The laser is a restricted device used in refractive procedures like LASIK.

The violation stems from the institute's January 2, 2013, press release, which describes the laser's benefits (e.g., "world's fastest excimer laser," "more precise outcomes") but fails to disclose material facts, specifically relevant risk information. This misbrands the device under sections 502(a) and (q) of the Act, which state a device is misbranded if its labeling or advertising is false or misleading.

FDA-approved LASIK lasers require disclosure of risks such as severe dry eye syndrome, potential need for glasses/contact lenses post-surgery, debilitating visual symptoms (halos, glare, starbursts, double vision), and vision loss. Contraindications specific to the laser should also be included.

Pacific Vision Institute is required to immediately cease promoting the WaveLight EX500 Excimer Laser System in violation of the Act. They must notify the FDA in writing within fifteen business days of the specific steps taken to correct the violations, explain how future violations will be prevented, and provide a timetable for any ongoing corrective actions. Failure to comply may result in regulatory actions including seizure