FDA WARNING_LETTER - ScottHyver Visioncare, Inc

The FDA issued a Warning Letter to Scott Hyver, M.D., owner of ScottHyver Visioncare, Inc., for misbranding the WaveLight Allegretto Wave Eye-Q Laser on its website (www.scotthyver.com). This excimer laser is a restricted device used in LASIK procedures.

The violation stems from the website's promotional statement: "The combination of speed, control and precision of the WAVE? Eye-Q laser means that patients are likely to enjoy LASIK outcomes that are equal to or even better than what they experience using glasses and contact lenses. For example, in the FDA clinical studies, 93% of the patients saw equal to or better than 20/20, and 76% better than 20/16."

The FDA determined this promotion misbrands the device under sections 502(a) and 502(q) of the Federal Food, Drug, and Cosmetic Act (the Act) because it fails to reveal material facts, specifically relevant risk information associated with the device's use. Section 201(n) of the Act requires disclosure of consequences that may result from device use. Common risks for LASIK procedures include dry eye syndrome, potential need for glasses/contact lenses post-surgery, debilitating visual symptoms (halos, glare, starbursts, double vision), and vision loss.

The FDA requires ScottHyver Visioncare to immediately