Latest News AOA Letter to FDA Requests a Recall of 1-800 Contacts’ Online Vision Test By Staff Friday, October 4, 2019 12:27 AM ST. LOUIS—The American Optometric Association (AOA) said Thursday it has asked the Food and Drug Administration (FDA) to recall 1-800 Contacts' online vision test, “in view of recent comparable action against a ‘strikingly similar’ online eye test.” AOA posted the announcement and a link to the letter it sent to the FDA on its website. "FDA should not permit the continued marketing of the 1-800 Contacts device until CDRH (FDA's Center for Devices and Radiological Health) has reviewed the safety and efficacy issues raised by the device,” AOA president Barbara L. Horn, OD, said in the association’s letter to the FDA.As VMAIL reported, the FDA issued a recall for Chicago-based Visibly’s online test on Aug. 8. According to the FDA document, “The Visibly Online Refractive Vision Test is being recalled since the firm has not received authorization from FDA to market the product.”Visibly CEO Brent Rasmussen told VMAIL in August that after pulling its online vision test off the market as requested by FDA, the company was continuing to work on providing the agency with the data it has requested about the test with the intent of getting the test back on the market. Visibly was previously known as Opternative. On Thursday, AOA noted that “1-800 Contacts appears neither to have applied for premarket clearance for its ExpressExam online eye test, nor met the standard of being substantially equivalent as a legally marketed visual acuity test." Horn made these points in the Sept. 25 letter to the FDA. For these reasons, the letter stated, 1-800 Contacts' prescription renewal platform violates the federal Food, Drug and Cosmetic Act (FDCA).A spokesperson for 1-800 told VMAIL Thursday in an email note that "like the FDA, 1-800 Contacts is committed to public safety and the well being of our customers, and we are working with the agency on the regulatory status of ExpressExam, our online vision exam. Based on past experience, we are not surprised that the AOA and its members oppose services like this that simplify eyecare and make it more accessible and affordable."The spokesperson added, "The AOA’s claim that ExpressExam requires premarket application (PMA) is a matter of opinion and not substantiated by the FDA. ExpressExam was developed with leading ophthalmologists and is different from Visibly. Our service enables a board-certified eye doctor to determine whether a customer's current prescription is working well and can be renewed. It is a continuation of the mission that got our company started 25 years ago: to get high quality, fresh contact lenses delivered to customers as fast and conveniently as technology allows."AOA also noted Thursday that the FDA issued its recall notice for Visibly's device because of a "lack of 510(k) clearance." The clearance refers to a premarket application (PMA) made to the FDA that a medical device, to be marketed, is at least safe and effective (substantially equivalent) as a legally marketed device that is not subject to premarket approval.“For more than three years prior to the recall, the AOA had vigorously pushed the issue with the federal agency due to concerns the test marketed by Visibly potentially posed serious health risks to the public and did not comply with federal law,” AOA noted.