AOA's ’31 in 31’ campaign spotlights bad actors in contact lens market
Shining a light on familiar boogeymen in the contact lens marketplace, an AOA advocacy campaign exposes illegal retailers and counterfeiters sidestepping legal requirements that protect patients’ eyes.
Throughout October, the AOA’s annual ’31 in 31’ letter-writing campaign directs federal regulators’ attention and scrutiny on those online retailers, brick-and-mortar shops and other sellers who distribute contact lenses without valid prescriptions, in direct violation of federal law. To date, the campaign has identified over 150 retailers—with support from doctors of optometry nationwide—that the AOA has directly contacted to inform of the U.S. law regarding the sale of contact lenses.
“Ensuring retailers comply with these federal regulations, established to protect patients, is absolutely essential,” says Melissa Barnett, O.D., AOA Contact Lens and Cornea Section chair.
The ’31 in 31’ campaign comprises letters to flagged sellers, reiterating the U.S. market rules set forth in the Fairness to Contact Lens Consumers Act (FCLCA) and the Contact Lens Rule, and specifically those requirements that contact lenses may only be furnished when a consumer presents a valid prescription from an eye doctor. While the AOA is not a regulatory enforcement agency, the letters are copied to both the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission for appropriate intervention.
As recently as last year, the ’31 in 31’ campaign had generated results with an online contact lens vendor initiating a voluntary recall of 1,362 pairs of contact lenses not cleared for sale by the FDA. The vendor, TTDeye.com, was brought to AOA’s attention by a report from a Virginia doctor of optometry noting an adverse event—severe keratitis and conjunctivitis—stemming from a patient’s use of those lenses.
“As CLCS chair and a doctor who specializes in contact lenses, I know the impact that poorly fitting contact lenses can have on the ocular surface,” Dr. Barnett says. “It is critical that patients ensure they are appropriately evaluated and fit for contact lenses to prevent related complications.”
Contact lenses are a safe, effective vision correction option when worn and cared for properly. However, poorly fitting or improperly used contact lenses can result in serious eye health and vision complications, which is why these FDA-regulated medical devices—even those that are only intended to change the appearance of the eye—require an eye doctor’s prescription and oversight to purchase as outlined by the FCLCA and Contact Lens Rule.
Despite these health and safety protections, bad actors and unaware retailers do sell contact lenses without prescriptions. In sidestepping these federal requirements, vendors not only sell contact lenses that may be inappropriate for patients’ eyes but also might peddle counterfeit or knock-off lenses that may contain harmful contaminants. In fact, a 2017 report from the FDA’s Chemistry Center in Ohio found that 60% of counterfeit and unapproved contact lenses tested were positive for microbial contamination commonly associated with serious eye infections and vision loss.
“These results support the contention that acquiring contact lenses without a prescription is a considerable threat to consumer health and safety,” the study authors note.
Support AOA’s contact lens advocacy
The AOA takes seriously its central mission not only serving as a reliable public resource on issues affecting eye health and vision care but also helping doctors of optometry safeguard patients’ eyesight. Doctors themselves play an integral role in the AOA’s contact lens advocacy.
Better documentation of illegal contact lens sales helps the AOA build a case for increased enforcement by the FTC and FDA. Here’s how doctors can report illegal sales or adverse events related to contact lenses:
- 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 exhibiting poor business practices.
- Email a de-identified case report to StopIllegalCLs@aoa.org to help bolster AOA’s advocacy against harmful contact lens practices.
For more information on illegal retailers or incident reporting, contact AOA’s Chief Strategy Officer Kara Webb.
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