The Food and Drug Administration (FDA) has issued a recall notice for the online refractive vision test developed by Chicago-based Visibly (formerly known as Opternative), and the test is no longer being offered on its website. The FDA found that Visibly is in violation of federal law by not receiving necessary FDA premarket approval.
The FDA had sent the company (then known as Opternative) a warning letter in October 2017 that it was violation of its 510(k) rule and requested that Opternative “immediately cease activities that result in the misbranding or adulteration of the On-Line Opternative Eye Examination Mobile Medical App device, such as the commercial distribution of the device through your online website.”
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective ("substantially equivalent") as a legally marketed device that is not subject to premarket approval.
At the time, the company responded with a statement that it was continuing to work with the FDA to comply with all regulatory requirements.
Currently, Visibly’s website hosts a doctor locator and coupon codes for discounts at online eyewear, lens, and contact lenses retailer sites. There is no prescription test, and all other links on the site have been disengaged.
The FDA’s recall notice, and the subsequent removal of the test from the Visibly site, is being lauded as a victory by the American Optometric Association, which has fought the online test for years and filed formal complaints against the test and its developer.
“For more than three years, the AOA has steadfastly and vigorously complained to the federal agency about concerns that the online test marketed by Visibly potentially posed serious health risks to the public and did not comply with federal law,” the AOA states.
"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," says AOA President Barbara L. Horn, O.D., in a post on the AOA website. "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."
The AOA originally filed a complaint against Visibly (Opternative) in April 2016 with the FDA, raising concern over potentially serious health risks and the company's noncompliance with federal medical device and patient safety laws. At that time, the AOA emphasized the lack of premarket approval (PMA) prior to marketing was a violation of the Food, Drug and Cosmetic Act (FDCA), and therefore should be removed from the market altogether.
EB has reached out to Visibly and will update when a statement is received.
You can read EB's reporting on Visibly and its online test here.