The American Optometric Association (AOA) is asking the FDA for a product recall of 1-800 Contacts’ online vision test, ExpressExam, in light of what the AOA says it considers recent comparable action against Visibly’s “strikingly similar” online vision test.
Specifically, on Aug. 8, the FDA posted a recall notice for Visibly’s device because of a “lack of 510(k) clearance.” (View it at bit.ly/FDArecallVisibly .) Similar to Visibly, 1-800 Contacts appears to have neither applied for premarket clearance for its ExpressExam online eye test, nor met the standard of being substantially equivalent to a legally marketed VA test, according to the AOA. (Read AOA President Barbara L. Horn’s full letter to the FDA at bit.ly/AOASept2019letter .)
In light of this, the AOA has recommended that the FDA should not permit the continued marketing of the 1-800 Contacts device until the FDA’s Center for Devices and Radiological Health (https://bit.ly/2P5MUCJ ) has reviewed the safety and efficacy issues raised by the device.
The AOA has voiced concern to a federal agency about 1-800 Contacts’ marketing and safety of the test in the past. For example, this past spring, 1-800 Contacts changed how it marketed its online eye test after the AOA complained about the name of the device to the Federal Trade Commission; specifically its use of the term “exam” in the name of the device. OM