FDAnews Device Daily Bulletin

Claims made in marketing materials for Bausch + Lomb contact lenses have landed the Rochester, N.Y., company an FDA warning letter. The letter recounts that in 2010, Bausch + Lomb asked the FDA for permission to repackage PureVision2 contact lenses for astigmatism in a new packaging solution. The request included revised labeling, which “included representations that the lenses were ‘HD High Definition’ and ‘ComfortMoist,’” according to the letter, issued June 11 and posted to the agency’s website this month. The FDA turned down the request in 2011.
Devices & Diagnostics Letter