The FDA, in a warning letter sent to Bausch + Lomb in early June, accused the company of marketing its PureVision2 contact lenses with an explicitly unapproved indication. The FDA referred to the device as “misbranded” and called for the company to immediately cease marketing PureVision2.

The letter stated that the company sought FDA approval for a revised labeling statement indicating the devices were “HD High Definition” and “ComfortMoist,” yet the FDA denied this request in May 2011.

In response to the letter, B+L says it acted in good faith in regard to the claims in question, but respects the FDA’s position and is actively working to resolve these concerns. The company has altered its marketing materials to reflect the FDA’s concerns and is working with suppliers and customers to update their websites. It also stopped marketing Pure- Vision2 and PureVision2 For Astigmatism as extended wear lenses.