AOA warns of hazard of cosmetic contact lenses without valid prescriptions

Decorative contact lenses can put a scare into Halloween

The AOA hopes to put a scare into retailers who illegally distribute corrective, novelty or bogus contact lenses in violation of federal law.

"No prescriptions are required, putting the public’s eye health and vision at risk."

The AOA's annual '31 in 31' letter-writing campaign gets under way in October. Over the course of the month, the AOA  calls out online vendors, brick-and-mortar shops and other sellers who may be distributing contacts to the public without valid prescriptions, in violation of the Fairness to Contact Lens Consumers Act (FCLCA) and Contact Lens Rule. Copied to both the Federal Trade Commission (FTC) and Food and Drug Administration (FDA), these letters are disseminated to businesses reported to AOA's hotline,

"All contact lenses, even those that are only intended to change the appearance of the eye. require a prescription," reads the letter signed by AOA President, Samuel D. Pierce, O.D. "The AOA would like for your company to be aware that the Food and Drug Administration regulates contacts as medical devices.

"As such, we believe it is dangerous to consumers to sell such devices to individuals within the United States without appropriate prescriber supervision," Dr. Pierce adds.

Although not a regulatory enforcement entity, the AOA takes seriously its central mission of serving as a resource to the public for reliable and current information related to eye and vision care, as well as safeguarding patients' eye health. As such, reiterating these violations with the industry enforcement agency, the FTC, helps put these concerns under federal spotlight.

The owner of a California company accused of illegally selling decorative contact lenses online-and the target of an AOA warning letter in 2017 during its '31 in '31' campaign-is facing a $60,000 fine and a ban on selling contact lenses under a proposed court order announced Dec. 6.

The seller, Lawrence Duskin, who does business as, and, was accused of violating the Fairness to Contact Lens Consumers Act (FCLCA) and Contact Lens Rule. The proposed order, filed by the U.S. Department of Justice on behalf of the Federal Trade Commission, says Duskin sold contact lenses to consumers without requiring a prescription, verifying prescriptions and keeping records in violation of the law. A federal court must approve the final settlement, which would require Duskin to pay $60,000 of a $575,000 fine to settle the FTC complaint. Read more here.

"Unfortunately, some companies are exploiting loopholes in the FCLCA to make sales," Dr. Pierce says. "Through our 31 in 31 campaign, we urge these companies to reverse their policies of illegally distributing corrective, novelty or bogus contact lenses without valid prescriptions in violation of federal law. These sales potentially put patients at risk for sight-threatening complications. It's a matter of public safety."

Adds Paul Velting, O.D., member of the Contact Lens and Cornea Section helping lead the AOA's Watchdog Group on contact lens: "We are trying to inform retailers that their current practices are in violation of FTC and FDA regulations, but we also want to inform the general public about the dangers of using contact lenses without the supervision of a trained optometrist. Since the AOA is not a regulatory enforcement agency, we need to maximize our role in protecting the eye health of Americans in every way possible."

Resources for doctors of optometry

An estimated 45 million Americans wear contact lenses, which provide many vision benefits provided they are worn safely. With Halloween a few short weeks away, the observance presents an opportunity for doctors of optometry to warn patients about the perils of purchasing decorative contact lens without prescriptions.

Decorative lenses are particularly popular among young adults and teenagers as accessories to their costumes. The U.S. Food and Drug Administration warns the public not to buy easily accessible decorative contact lenses from street vendors, salons and beauty supply stores, boutiques, flea markets, seasonal retailers, convenience stores and internet sites that don't require prescriptions.

The danger of purchasing contact lens at these locations? No prescriptions are required, putting the public's eye and vision health at risk.

Optometrists are growing increasingly concerned about the risks for patients. Allergic reactions or bacterial eye infections from contaminated, poorly fitted decorative lenses can occur rapidly, causing a painful corneal ulcer or even significant damage to the eye's ability to function, which could lead to irreversible sight loss. The AOA regularly underscores the essentialness of annual, comprehensive eye examinations.

Besides its 31 in 31 campaign, the AOA also has prepared resources for doctors of optometry to promote patient safety against unprescribed decorative lenses here (member log-in required) including an infographic, template press release and sample social media posts.

"We're certainly looking to help the general public realize that contact lenses are a regulated medical device-they are not a commodity," Dr. Velting says. "I don't believe most people realize the true risk of contact lenses when not worn properly or monitored by their optometrist."

Want to report illegal activity?

Better documentation of illegal contact lens sales helps make the case for increased enforcement at the federal level. That's why AOA asks doctors of optometry to report illegal sales or complications to AOA, FTC and the 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.
Email a de-identified case report to to help bolster AOA's advocacy against harmful contact lens practices.

For more information on illegal retailers or incident reporting, contact AOA's Director for Coding and Regulatory Policy Kara Webb.

October 4, 2018

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