Busted: Feds seize hundreds of illegal, counterfeit contact lenses

Help support AOA's contact lens advocacy by reporting incidents of patient harm or illegal contact lens sales to AOA, the FTC and FDA. Report violations here or continue reading for more information.

Federal law enforcement has seized hundreds of illegal, counterfeit contact lenses as part of multi-state operations that underpin the AOA's argument for stricter enforcement against market violators.

Only days prior to Halloween, Homeland Security Investigations (HSI) agents removed more than 300 counterfeit contact lenses from store shelves in west Texas with more busts anticipated in the days ahead. In fact, federal law enforcement agencies have active anti-counterfeiting operations spanning at least three additional states—Arkansas, Louisiana and Mississippi—targeting retailers dealing in seasonal fakeries, such as counterfeit makeup and cosmetics, sports jerseys and contact lenses.

One such campaign, "Operation Safety Claus" in New Orleans, has HSI partnering with U.S. Customs and Border Protection officers and other federal agencies throughout the holiday season to disrupt counterfeits entering the Port of New Orleans with an emphasis on contact lenses. Citing not only the very real health threat of wearing nonprescribed, knock-off contact lenses, the law enforcement agencies also noted that counterfeits could have criminal consequences.

Beyond an intellectual property crime, counterfeit items are often used to fund international and transnational criminal organizations and, in the case of counterfeit contact lenses especially, put the public at risk with little recourse, states HSI New Orleans Deputy Special Agent in Charge Gilbert Trill, in a release.

"You're not going to be able to sue an illegal activity or transnational criminal organization," Trill notes.

But, HSI and CBP aren't the only agencies looking to crack down on illegal contact lens sellers. Earlier this August, California Department of Public Health (CDPH) investigators seized 123 pairs of misbranded, decorative contact lenses from a Sacramento business. The CDPH notes the products—marketed as 'beauty accessories' under the names Secret Cosmetic Contact Lens and Crazy Premium Cosmetic Contact Lens—not only failed to meet labeling requirements but also were sold without a written prescription from a licensed practitioner.

"It is potentially harmful for consumers to purchase and wear contacts without a prescription," noted Alan Barcelona, California Statewide Law Enforcement Association president, in a news release.

Classified as medical devices by the Food and Drug Administration (FDA), contact lenses require a prescription from a licensed practitioner. That's because poorly fitting lenses, lax wear and care protocol, and the potential of contamination or allergic reaction from counterfeit lenses could cause vision-threatening complications.

Published in the Journal of Forensic Sciences, a 2017 FDA case report detailed how the majority of noncorrective, decorative contact lenses obtained without a prescription tested positive for the kinds of microbial contamination commonly found in hospital waste water or spoiled food. Respectively, Pseudomonas aeruginosa and Bacillus cereus were just a pair of microorganisms identified in the FDA's examination of more than 300 contact lenses that investigators obtained from sources such as import seizures, novelty stores, tattoo parlors, flea markets and internet marketplaces.

Additionally, nearly half of the 29 different brands of noncorrective, decorative contact lenses examined were found to have at least one sample positive for microbial contamination, while 60% of counterfeit contact lenses tested positive. These microbes are the same ones commonly associated with serious eye infections and vision loss, including microbial keratitis and bacterial endophthalmitis.

AOA advocates for contact lens safety, enforcement

Popular with roughly 45 million Americans, contact lenses are a safe, effective vision correction option when worn and cared for properly. However, poor-fitting or improperly used contact lenses can result in serious eye and vision conditions, which is why these medical devices require an eye doctor's prescription and oversight. So, too, it's why the FDA and Centers for Disease Control and Prevention advise consumers that contact lenses are not "one size fits all" and that regular, comprehensive eye examinations are necessary for ensuring optimal health.

Unfortunately, vendors and sellers still find ways to distribute contact lenses without prescriptions, either knowingly or unwittingly in violation of federal law. While not a regulatory enforcement agency, the AOA prioritizes serving as a leading public resource for safe, healthy contact lens wear and care, and regularly meets with federal officials to discuss robust responses to illegal, improper contact lens sales.

Earlier this year, the AOA alerted one of the largest global e-commerce retailers, Amazon, to potential violations involving spurious contact lens sales on its site. Not only violating federal law but also its own medical device policy, Amazon's marketplace listed noncorrective costume contact lenses for sale without a prescription and included faulty contact lens care guidance.

Most recently, AOA's '31 in 31' letter-writing campaign—now in its fourth year—will have informed 124 retailers of the federal law regarding prescription requirements, while also apprising the FDA and Federal Trade Commission on potential violations.

See something, say something

Have you encountered a patient harmed by counterfeit or illegally procured contact lenses, or suspect a business of selling lenses without a prescription? Better documentation of illegal contact lens sales helps make the case for increased enforcement at the federal level. Help AOA's contact lens advocacy by reporting these examples of patient harm or illegal sales to the AOA, the FTC and FDA.

Here's how:

• Report a website illegally selling contact lenses.
• Report an adverse event related to contact lenses.
• Report problems with decorative contact lenses.
• Report a contact lens seller with poor business practices.
• Report a de-identified case report to help AOA advocate for increased contact lens enforcement.

For more information on suspicious contact lens retailers or incident reporting, contact the AOA's Director of Coding & Regulatory Policy Kara Webb at kcwebb@aoa.org.