FDA WARNING_LETTER - Sauflon Pharmaceuticals, LTD

The FDA issued a Warning Letter to Sauflon Pharmaceuticals, LTD, regarding their "i-Clean' antibacterial contact lens soaking case." The FDA determined that the product is a medical device marketed in the U.S. without required marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act.

The "i-Clean" case's labeling, including the screw top lens cap and display placard, states "antibacterial," indicating an antibacterial use. While Sauflon Pharmaceuticals obtained 510(k) clearance for a different device, the Flat Colored Contact Lens Case (K052809), in 2005 for storage during chemical disinfection, they have not obtained 510(k) clearance for the "i-Clean' antibacterial contact lens soaking case."

This constitutes several violations: the device is adulterated under section 501(f)(1)(B) of the Act because there is no approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) of the Act for failure to notify the FDA of intent to introduce the device into commercial distribution as required by section 510(k).

Sauflon Pharmaceuticals is required to immediately cease dissemination of promotional materials for the "i-Clean" case and take prompt action to correct the violations. Due to the serious nature of the violations, "i-Clean"