Bausch & Lomb ELC SPL – FDA Warning Letter, Jun 30, 2012

On June 11, 2012, the FDA issued a Warning Letter to Bausch & Lomb, Inc. regarding their PureVision 2 (balafilcon A) contact lenses. The FDA found that Bausch & Lomb was marketing these lenses in the U.S. without appropriate premarket approval, violating the Federal Food, Drug, and Cosmetic Act.

The FDA's review of Bausch & Lomb's website and promotional materials revealed misleading claims for the PureVision 2 lenses. Specifically, the company was marketing the lenses with "HD High Definition" and "ComfortMoist" claims, despite these claims not being approved by the FDA. A supplement (P980006/S015) submitted by Bausch & Lomb on July 22, 2010, requesting approval for these claims, was deemed "not approvable" by the FDA on May 26, 2011.

As a result, the PureVision 2 devices are considered adulterated under section 501(f)(1)(B) of the Act because they lack an approved Premarket Approval (PMA) or an approved investigational device exemption. Furthermore, the devices are misbranded under section 502(a) of the Act, as the "HD High Definition" claims on the carton labeling are not substantiated by data, and the FDA had previously objected to their inclusion.

The FDA