U.S. Immigration and Customs Enforcement (ICE), U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) have combined efforts to make several hundred seizures totaling around 100,000 pairs of counterfeit, illegal and unapproved contact lenses. The enforcement actions, coordinated from the ICE-led National Intellectual Property Rights Coordination Center (IPR Center), were conducted under the FDA-led initiative dubbed Operation Double Vision, an ongoing effort to target the illicit importation and distribution of counterfeit and unapproved contact lenses that present a significant health and safety hazard to the American public.
“Criminal elements will capitalize on the excitement of the holiday season by selling substandard, dangerous counterfeit and illegal items with no regard for the health and safety of consumers,” said ICE Homeland Security Investigations Executive Associate Director Peter Edge. “Our agents are committed to collaborating with external agencies to develop effective operations and conduct aggressive investigations into the distribution of fake goods that threaten the American public with lengthy medical procedures and strenuous rehabilitation programs.”
Several investigations into the trafficking of counterfeit and unapproved contact lenses have included testing, which has revealed high levels of bacteria that could cause significant health problems. The presence of bacteria and other toxins are the result of poor sanitary conditions during packaging and improper storage during the shipping process. Additionally, the coloring on decorative contact lenses may be made of lead-based materials that leach directly into the eye. Therefore, consumers searching for any type of contact lenses should visit an eye doctor, obtain a prescription and purchase them from a licensed provider.
“A valid prescription helps ensure consumers get contact lenses that are determined to be safe and effective by the FDA. Without it, people can risk serious eye injuries or loss of eyesight for one night of fun,” said George M. Karavetsos, Director, FDA’s Office of Criminal Investigations. “We will continue to pursue and bring to justice those who attempt to circumvent the regulatory process and put the public’s health at risk.”
Forty million Americans wear contact lenses, which the FDA regulates as medical devices under federal law. National studies conducted for optometrists have revealed that 11 percent of consumers have worn decorative contact lenses, but a majority of those individuals purchased them without a prescription, and 59 percent of people using disposable contact lenses wear them for longer than recommended.
"You'd never buy a new hip at a flea market and you should never buy a medical device like contact lenses at one either," said Georgia Optometric Association President Dr. Ben Casella. "If you're not careful, one night of using knock-off lenses to change your appearance can mean a permanent change in your ability to see for the rest of your life."
Founded in 2000, the IPR Center – formally codified in the Trade Facilitation and Trade Enforcement Act of 2015 – is one of the U.S. government's key weapons in the fight against criminal counterfeiting and piracy. The center uses the expertise of its 23 member agencies to share information, develop initiatives, coordinate enforcement actions, and conduct investigations related to IP theft. Through this strategic interagency partnership, the IPR Center protects the public's health and safety, the U.S. economy and the war fighters