Visibly, a Chicago-based startup offering virtual eye exams, has halted its online testing after the FDA issued a class 2 device recall Aug. 8.
According to the FDA notice, Visibly never received the necessary 510K authorization from the agency to market its proprietary Online Refractive Vision Test. By the time of the recall, the test was available in more than 30 states, with pricing starting at $35.
Upon observing that Visibly had quietly removed the test from its website, the American Optometric Association released a statement Aug. 22 commending the FDA's actions, which reflect repeated complaints from the AOA to the agency regarding Visibly's offerings.
"Optometrists and other physicians know that eye exams are essential care and that new health technologies must always enhance the doctor-patient relationship and help deliver improved outcomes," AOA President Barbara Horn, OD, said in the statement. "They must also comply with the law — that's exactly what the AOA and our state associations have insisted on through the information we provided to the FDA and other agencies in this matter, and we're proud that it appears to have made a difference."
Becker's Hospital Review has reached out to Visibly for comment and will update this article with their response.