FDA Warns about Counterfeit Decorative Contact Lenses

With Halloween just around the corner, the U.S. Food and Drug Administration (FDA) is warning about the risks associated with counterfeit decorative contact lenses. In a collaborative effort with the U.S. Immigration and Customs Enforcement’s Homeland Security Investigations and U.S. Customs and Border Protection, the FDA’s Office of Criminal Investigations is increasing efforts to seize fake contact lenses. Illegally imported counterfeit contact lenses are not FDA-approved, and can lead to serious injuries and blindness in users.

The ICE-led National Intellectual Property Rights Coordination Center in Washington is coordinating these efforts, which is called “Operation Double Vision.” There have been 74 seizures including a total of over 20,000 pairs of counterfeit and decorative contact lenses this year alone thanks to Operation Double Vision.

Peter Edge, HSI Executive Associate Director, said “Make no mistake, contact lenses are medical devices that should be prescribed by trained professionals. Unregulated and poorly constructed lenses sold without a prescription pose serious health risks to consumers,” he states in the ICE press release. ”Halloween is a fun and festive holiday, and nobody wants to see those celebrations end with a trip to the ER.”

Consumers should only buy contact lenses from trained, licensed professionals. The FDA warns against purchasing lenses from Halloween or costume shops, salons, beauty supply stores and other locations. The lenses should also not be purchased online if they seller does not require a prescription. By law, authorized contact lenses distributors must ask for a prescription.

Philip J. Walsky, acting director of FDA’s Office of Criminal Investigations said in the release “Our concern is that consumers who buy and use decorative contact lenses without a valid prescription can run significant risks of eye injuries, including blindness…It is always better to involve a qualified eye care professional and protect your vision.”

“You’d never buy a heart valve at a gas station and you should never buy a medical device like contact lenses at one either,” Georgia Optometric Association president Dr. Jeffrey Hackleman said. “You only get one pair of eyes and risking a lifetime of vision for a quick thrill is quite frankly not being vision smart. Contact lenses are like sponges that can absorb bacteria and cause an infection if not handled properly. A lifetime of good vision is so much more important than a cheap Halloween accessory.”