Federal Agencies Warn Against Counterfeit Decorative Contact Lenses

WASHINGTON, D.C. (Press Release) — With Halloween rapidly approaching, federal officials are warning the public about the dangers associated with counterfeit decorative contact lenses. Decorative and colored lenses are becoming increasing popular, especially around this time of year.

Currently, the Food and Drug Administration’s (FDA) Office of Criminal Investigations (OCI), U.S. Immigration and Customs Enforcement’s (ICE) Homeland Security Investigations (HSI) and U.S. Customs and Border Protection (CBP) are working to seize counterfeit contact lenses, illegally imported decorative lenses, and lenses unapproved by the FDA. This ongoing effort, which is being coordinated with the ICE-led National Intellectual Property Rights Coordination Center (IPR Center) in Washington, is being called “Operation Double Vision.” As a result of the operation, this year alone there have been 74 seizures with a total of more than 20,000 pairs of counterfeit and decorative contact lenses being seized.

“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,” said HSI Executive Associate Director Peter Edge. ”Halloween is a fun and festive holiday, and nobody wants to see those celebrations end with a trip to the ER.”

Officials are warning consumers not to buy contact lenses from such places as Halloween or novelty shops, salons, beauty supply stores, or online if the site doesn’t require a prescription. Although many places illegally sell decorative contact lenses to consumers without valid prescriptions for as little as $20, these vendors are not authorized distributors of contact lenses, which by law require a prescription.

Because of the inherent medical risks, it is illegal to purchase or sell contact lenses of any kind without a prescription from an ophthalmologist, optometrist or a specially licensed optician under the supervision of an eye doctor. Decorative contact lenses can typically be ordered from the office that conducts the eye exam and contact lens fitting. The Fairness to Contact Lens Consumers Act gives the consumers the right to obtain a copy of their contact lens prescription, allowing them to fill that prescription at the business of their choice, including online discount sites. Various legitimate stores and websites sell decorative lenses but consumers should avoid buying these lenses from anywhere that does not require a valid prescription.

“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,” said Philip J. Walsky, acting director of FDA’s Office of Criminal Investigations. “It is always better to involve a qualified eye care professional and protect your vision.”

According to a recent national study conducted for optometrists, 11 percent of consumers have worn decorative lenses, and of those, 53 percent purchased them without a prescription. In some states, contact lenses are available at gas stations, flea markets, beauty supply shops and pawn shops.

“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,” said Dr. Jeffrey Hackleman, president of the Georgia Optometric Association. “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.”

Medical experts advise consumers interested in buying decorative lenses to get an eye exam from a licensed eye doctor, even if you think your vision is perfect; to get a valid prescription that includes the brand name, lens measurements and an expiration date; to buy the lenses from a seller that requires you to provide a prescription, regardless of whether you shop online or in person; and to follow directions for cleaning, disinfecting, and wearing the lenses. Also, consumers should not expect their eye doctor to prescribe anime, or circle lenses, which give the wearer a wide-eyed, doll-like look, as these have not been approved by the FDA. Finally, an eye doctor should be seen right away if there are signs of eye infection, including redness, lasting eye pain or decrease in vision.

The HSI-led IPR Center is one of the U.S. government’s key weapons in the fight against criminal counterfeiting and piracy. Working in close coordination with the Department of Justice Task Force on Intellectual Property, the IPR Center uses the expertise of its 21-member agencies to share information, develop initiatives, coordinate enforcement actions and conduct investigations related to intellectual property theft. Through this strategic interagency partnership, the IPR Center protects the public’s health and safety and the U.S. economy.