A scary disconnect

October 25, 2021
Halloween is nearing and there’s nothing more haunting than this: Some patients and regulators don’t believe contact lenses pose any risk to consumers.
Decorative contact lenses

Excerpted from page 48 of the September/October 2021 edition of AOA Focus.

Want eyes like a zombie? A cat? A vampire? You can find it all in costume contact lenses.

While October is peak season for illegal costume contact lens sales, the problem is not relegated to one month of the year. An increasing number of illegal contact lens sales are occurring year-round, sometimes with disastrous consequences.

One of the largest public misconceptions in our profession is the notion that contact lenses are consumables, not medical devices. As evidenced by the proliferation of both online contact lens and glasses retailers, patients are now—more than ever—seeking the most convenient vision options at the lowest price. The difference for contacts, however, is the unperceived yet significant risk to eye health and vision.

An article published in May by The Federalist laments the regulatory burden assessed to contact lens consumers in the United States. The article compares U.S. consumers to many of our European counterparts who can purchase contacts from a vending machine, “in the same way Americans can purchase a Snickers or Diet Coke.” While most of us could agree that excessive regulations can sometimes stand in the way of progress, deregulation should be aptly applied to products, not medical devices with the potential for harm. While extremely safe when used appropriately, we’ve all seen the damage these devices can do without proper fitting and instruction.

The problem has many faces: Non-FDA-approved contacts (mostly noncorrective costume contacts), counterfeit contacts posing as FDA-approved lenses, FDA-approved contacts sold without a prescription, and startup companies that many times rebrand approved lenses but sell without a prescription. A 2017 study found that 60% of all counterfeit lenses tested “were positive for microbial contamination,” and of the 29 different brands of noncorrective contact lenses tested, almost half (48%) “had at least one sample positive for microbial contamination.” This is certainly a recipe for disaster when paired with absent or inadequate instruction from an eye care professional.

Even FDA-approved lenses can have disastrous effects when used inappropriately. According to a study in Ophthalmology, the place of purchase for contact lenses was found to be an independent risk factor for contact lenses, with online purchase increasing the risk for microbial keratitis. While counterfeit, contaminated lenses could account for some of this increased risk from online purchase, I believe much of it comes from the absence of proper fitting and instruction on handling and replacement.

Many companies have emerged offering rebranded, older contact lens technology at a discount or subscription service. Almost all of them do so without even offering a fitting set. With many of these companies then selling their contacts without even the possibility of a prescription being written, why hasn’t anything been done to stop them?

We’ve all seen patients with these lenses in our office, and many of us have seen complications, sometimes significant, from the use of these lenses. We’re in the trenches, we see the problem firsthand. The disconnect occurs because those in the position to make our laws and regulations have the same perception as our patients: “Contact lenses are products with little to no risk to consumers.”

None of us can sway the minds of our legislators alone. We know if they were in the trenches with us, seeing the risks and complications that can occur when not used appropriately, their view of contact lenses as products would change. No, you don’t have to write a letter every time you see a patient who has purchased contacts illegally. All you have to do is notify the AOA.

Lastly, patient education on this issue is key. Most of the patients I’ve seen with illegally purchased contacts had no idea they were doing so. It’s our job to inform the patients in our communities on the risks they could be taking. Be proactive this year. Let your patients know that their fake zombie eyes could turn into real zombie eyes if they’re not careful.

How you can help stop illegal sales

The AOA has updated its illegal sales tracker to include new ways for doctors to report illegal sales of contact lenses, eyeglasses and new or emerging eye care devices that may pose risks to patient safety. Fill out the brief form to easily alert the AOA. For questions or comments, please contact stopillegalcls@aoa.org. If you are interested in combating illegal contact lens sales, consider joining the Contact Lens & Cornea Section.


Written by Paul Velting, O.D., a member of the AOA’s Contact Lens & Cornea Section.

Disclaimer: The information contained in this article represents the opinion of the author and not the AOA. These are not clinical practice guidelines, nor has the evidence been peer reviewed. There are additional aspects to this topic that may not be presented, or considered, based on the specifics of the case.

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