FDA WARNING_LETTER - 20/20 Institute - December 18, 2012

On December 18, 2012, the FDA issued a Warning Letter to Mark S. Danzo, O.D., Founder of 20/20 Institute, Indianapolis Lasik, regarding the promotion of the WaveLight Allegretto Wave Eye-Q Laser on its website (www.2020lasikindianapolis.com). The FDA determined that the promotion misbrands the device under sections 502(a) and (q) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §§ 352(a) and (q).

The WaveLight Allegretto Wave Eye-Q Laser is a restricted device used in refractive procedures like LASIK. The website's "Custom Lasik" and "Lasik 101: Lasik Safety" pages made claims about the laser's accuracy, speed, and low complication risk (less than 0.5%). However, the FDA found that the website failed to reveal material facts, including relevant risk information such as contraindications, warnings, precautions, and adverse events, which is required for restricted devices. Common risks associated with LASIK lasers, as noted by the FDA, include severe dry eye syndrome, potential need for glasses/contact lenses post-surgery, debilitating visual symptoms (halos, glare, starbursts, double vision), and vision loss.

This failure to disclose material facts constitutes misbranding