AOA’s '31 in 31’ campaign confronts illegal contact lens sellers, adverse events
Insecure, illicit, infectious—three I’s no one wants near their eyes, which is why the AOA is issuing a Halloween warning against illegally sold contact lenses and urging doctors to report such retailers.
As Americans still grapple with an ongoing COVID-19 public health emergency that has prompted calls to cancel large social gatherings and even the time-honored tradition of trick or treating, there hasn’t been a Halloween in recent memory where the emphasis on safety has been so eminent. But even as the idea of Zoom parties and masked costumes become the cautious craze to lower exposure risk, the dangers of illegally procured decorative contact lenses remain high.
“Decorative contact lenses are a popular accessory come Halloween that many people mistakenly assume are not only one-size-fits all but also can safely be ordered online or simply purchased from a costume store,” says Jason Compton, O.D., AOA Contact Lens and Cornea Section chair. “That’s absolutely not the case—all contact lenses, whether corrective or decorative, are medical devices that require the fit and prescription of an eye doctor. Without this critical step, without an up-to-date contact lens prescription to purchase your lenses, people run the very real risk of putting a product on their eye that could threaten their vision and overall ocular health.”
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—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 Fairness to Contact Lens Consumers Act and the Contact Lens Rule.
Despite these health and safety regulations, bad actors and unaware retailers sell contact lenses without a prescription in violation of federal law. In sidestepping these requirements, vendors not only peddle counterfeit or knock-off lenses unsuitable for healthy wear but also lenses that may contain harmful contaminants. In fact, a 2017 Food and Drug Administration (FDA) report found that 60% of counterfeit contact lenses tested positive for microbial contamination commonly associated with serious eye infections and vision loss.
If decorative contact lenses are an essential part of your Halloween costume, schedule an appointment with a doctor of optometry who can help find a safe, healthy option for your eyes. And as for those retailors …
AOA, doctors keep pressure on illegal sellers
Throughout the month of October, the AOA is taking action once again with its annual ‘31 in 31’ letter-writing campaign to direct 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 contacted to inform of the U.S. law regarding the sale of contact lenses. While the AOA is not a regulatory enforcement agency, these letters are copied to both the FDA and the Federal Trade Commission (FTC) for appropriate intervention as necessary, and recently those efforts yielded a considerable win for patient safety.
In April, the AOA followed up on a report from a Virginia doctor who reported an instance of patient harm related to the use of contact lenses sold without a prescription through TTDeye.com. Despite adhering to a good contact lens hygiene regimen, the patient presented with severe keratitis and conjunctivitis related to her contact lens usage.
Previously flagged by the AOA’s 2019 ‘31 in 31’ campaign, TTDeye.com sold lenses under a variety of product names through its website, sans prescription, and shipped them direct to consumers. The AOA took concerns directly to the FDA and FTC, and on June 24, the FDA posted a public notice announcing Chengdu Ai Qin E-Commerce Co., Ltd., had initiated a voluntary recall of 1,362 pairs of colored contact lenses and that such lenses had not been cleared for sale by the FDA.
“The relevant series of contact lenses have been found to be distributed without FDA clearance and may pose a threat to health,” noted an announcement from the company.
Unfortunately, instances of patient harm from contact lenses sold through retailers’ exploitation of loopholes in the existing regulatory framework or outright disregard of the laws are common. So much so that the AOA made a point to underscore the necessity of increased enforcement of online contact lens sales in recent updates to the FTC’s Contact Lens Rule.
The bottom line: If you see something, say something.
“As doctors of optometry, we know all too well the consequences of improper contact lens wear and care,” Dr. Compton says. “When we encounter these instances, especially when there’s a contact lens vendor that’s sidestepping health and safety laws, it’s important that doctors report their findings so appropriate actions can be taken to protect our patients.”
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 integral roles in the AOA’s contact lens advocacy.
Better documentation of illegal contact lens sales helps the AOA build a case for increased enforcement among 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 contact lens sellers exhibiting poor business practices.
- Email a de-identified case report to StopIllegalCLs@aoa.org to help bolster AOA advocacy against harmful contact lens practices. Include the state where you practice in your email.
For more information on illegal retailer or incident reporting, contact the AOA's Director for Coding and Regulatory Policy Kara Webb at email@example.com.
The global e-commerce retailer again came to the AOA’s attention over posts from contact lens sellers that didn’t appear to meet FCLCA patient protection provisions requiring valid prescriptions.
Online contact lens retailer, Vision Direct UK, to halt sales without required prescriptions after AOA complaints
After years of the AOA alerting the company of regulatory and legal requirements regarding contact lens sales, Vision Direct recently announced on its website that it was halting its no-prescription service.
The advocacy collaborative fighting for patient safety and the doctor-patient relationship reports on a productive 2020, despite COVID-19 challenges, and recently welcomed Alcon as its newest member.