The American Optometric Association (AOA) has praised a US Food and Drug Administration (FDA) Class 2 Device recall of the Visibly Online Refraction Vision Test.
The reason given by the FDA for the 8 August recall was that Visibly (formerly Opternative) had not received FDA authorisation to market the test, which forms part of the Visibly Vision Test Solution.
AOA president, Barbara L. Horn, commented: “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.
“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.”
Former AOA president, Christopher J. Quinn, added: “In our initial complaint to the FDA we called upon the agency not to permit the continued marketing of this online vision test until the agency fully reviewed the safety and efficacy issues raised by the device. This FDA recall is a clear response to AOA’s call to action to protect patients.”
Read more about the AOA campaign here.