Federal agencies warn against counterfeit decorative contact lenses

WASHINGTON — 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 increasingly 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."

"Even though Halloween approaches, consumers shouldn't let a good deal or great costume blind them to the dangers of counterfeit decorative contact lenses," said HSI Executive Associate Director James Dinkins. "What's truly scary is the damage these counterfeit lenses can do to your eyes for a lifetime."

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 John Roth, director of FDA's Office of Criminal Investigations. "It is always better to involve a qualified eye care professional and protect your vision."

"Contact lenses are a medical device and it is smart to purchase them from a medical professional who will fit them to your eye and provide you with instruction on the use and care of the lenses," said Dr. Glenda Brown, president and a member of the Georgia Optometric Association. "Consumers who buy lenses that were manufactured and sold illegally can experience infections, corneal ulcers and even blindness. 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.