FDA WARNING_LETTER - Hoya Surgical Optics, Inc.

On August 2, 2011, the FDA issued a Warning Letter to Hoya Surgical Optics, Inc., specifically to Global President and CEO Mr. Thomas Dunlap, for marketing intraocular lenses, iSymm models FC-60AD and PC-60AD, in the U.S. without marketing clearance or approval. These products are classified as devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) and are intended for visual correction of aphakia after cataract surgery.

The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) identified the violation through a review of the firm's website and a letter submitted to the FDA dated January 14, 2011. The letter indicated that between August 1, 2009, and July 31, 2010, Hoya Surgical Optics shipped and sold a significant number of these lenses (b)(4) of model FC-60AD and (b)(4) of model PC-60AD.

The iSymm models FC-60AD and PC-60AD are deemed adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) application under section 515(a) or an approved investigational device exemption (IDE)