Opternative eye exam is unlawful, claims American Optometric Association

An online eye exam service in the US is in breach of the Food, Drug and Cosmetic Act (FDCA), the American Optometric Association has alleged in a complaint to the country’s Food and Drug Administration (FDA).

The AOA stated that Opternative’s ‘vision test’ application posed a significant health risk to the public and argued that the company’s continued marketing to consumers without federal approval was in violation of the FDCA. As a result, the application should be taken off the market until the FDA had reviewed the product’s claims, safety and efficacy, the AOA said.

FDCA requirements state that new devices must receive premarket approval (PMA) prior to marketing, unless that device has been cleared as substantially equivalent to an already marketed device or has otherwise been determined by FDA not to require a PMA. The AOA alleged there was no record of this and therefore Opterantive was marketing the product unlawfully.