The American Optometric Association reports that Amazon’s marketplace no longer displays noncompliant, decorative contact lens vendors following complaints from the AOA.
The AOA explains that it had alerted the e-commerce retailer to potential violations of federal law and its own medical device policy.
In a Feb. 27 letter to Amazon, the AOA emphasized that contact lenses — whether corrective or plano — are U.S. Food and Drug Administration-regulated medical devices that not only require a prescription from a licensed practitioner for purchase, but also fall under Amazon’s own policy for “Medical Devices and Accessories.” That policy mandates how sellers must abide by all federal, state and local laws, which in this case, the AOA noted, includes patient protection provisions of the Fairness to Contact Lens Consumer Act (FCLCA).
Per federal law, vendors “may sell contact lenses only in accordance with a contact lens prescription for the patient that is (1) presented to the seller by the patient or prescriber directly or by facsimile; or (2) verified by direct communication.”
AOA’s letter noted: “The contact lenses available for sale on Amazon are sold entirely without a prescription, which we believe is an FCLCA violation.” Furthermore, “in addition to sales via (Amazon’s) platform raising legal questions related to the FCLCA, the guidance provided by sellers regarding these FDA-regulated medical devices is very concerning.”
The AOA’s letter document instructions from vendors such as “… gently press the contact lens opposite clockwise or counterclockwise turn 30 times [sic], and put in a box for a new care solution … if you do not use for a long time, please put in the box, soak with care solution [sic], replace the care solution every three days.”
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Such guidance is “wholly inappropriate and dangerous,” the AOA states in a post on its website. It notes that proper physician oversight is necessary for medical devices that require a physician’s prescription.
According to AOA:
In response, Amazon thanked AOA for its diligence and reiterated its own medical devices policy while stating the company will take appropriate action when products are reported for legal non-compliance. As of June 4, those violating posts that AOA first identified and reported have been removed. The AOA will continue to monitor the site and report retailers.
