The U.S. Food and Drug Administration (FDA) has identified six Southern California businesses which have been selling unapproved cosmetic contact lenses without prescriptions. FDA pinpointed these companies through an undercover investigation which has been dubbed “Operation Cat Eyes.” Local and federal agents went to retail stores, including some that were open specifically for Halloween, and purchased the contact lenses. In two cases, the contact lenses purchased by the undercover agents were found to be contaminated with Bacillus cereus, bacteria that can lead to severe infections and blindness.
All contact lenses sold in the United States, including those intended solely for decoration, are subject to FDA regulation. Just as with prescription contacts, FDA considers decorative contact lenses to be medical devices and requires that they be prescribed by a medical professional. There are many risks of using contacts, including scratches, allergic reactions, infections, and blindness, so selling the lenses without meeting proper requirements can put consumers in danger.
FDA is taking legal action against the companies who sold the unapproved contact lenses. All of the defendants have been ordered to appear in federal court on December 9, 2014.
It’s always best to ensure you fully understand FDA’s requirements before selling products in the United States. If you plan to sell glass lenses or contact lenses in the USA, Registrar Corp can assist you through the regulatory process. We can help register your establishment with FDA, list your devices, review your labels for FDA compliance, and more. For assistance with FDA regulations of medical devices, contact Registrar Corp at 1-757-224-0177 or through our 24 hour Live Help service: https://www.registrarcorp.com/livehelp.