Visibly online screening test recalled by the FDA

The American Optmoteric Association (AOA) celebrates a victory as the US Food and Drug Administration (FDA) has forced Visibly (formerly Opternative) to withdraw its online vision screening test.

The online vision test, which has now been recalled by the company, has been under scrutiny for almost three years to deem whether it is “at least as safe and effective, or substantially equivalent” to its offline counterparts. The AOA was concerned that the online test potentially posed serious health risks to the public and did not comply with federal law, and lobbied the FDA about the online test not undergoing premarket review.

Launched in 2015, the test was created as a tool for patients who didn’t require a yearly eye exam to obtain a new prescription. Visibly were careful to point out that it provided only a refraction eye exam, and not the comprehensive exam that would be received at an eye doctor. Optometrists warned that members of the public might misunderstand the screening as an official health exam.

“Visibly has been held accountable for violating the law,” says Barbara L. Horn, OD and AOA president, “and the AOA is grateful to the FDA for addressing the issue we raised back in 2016.”