FDA Enforcement Action Backs AOA Safety Complaint About Online Vision Test

October 30, 2017

The American Optometric Association (AOA), the nation's leading authority on eye health and vision care, applauded a just-released Food and Drug Administration (FDA) letter warning Opternative to "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."    

"The FDA's enforcement action against Opternative is major victory for public health and for the tens of millions of Americans who need and deserve access to the quality care to safeguard their health and vision. The AOA and our member doctors across the country are gratified that the FDA has taken such decisive action to address the urgent health and safety violations we identified, reported and relentlessly followed-up on. It is our hope that we are a step closer to holding all companies that would place profits ahead of patient care fully accountable for their actions.  

As a consistent advocate in ensuring that patients have access to medically-recognized eye health care and to protect patients from companies, platforms or services that may put their health at risk, the AOA filed a detailed complaint in 2016 exposing Opternative's 'vision test.' The AOA outlined for the agency potentially serious health risks and documented the company's non-compliance with Federal medical device and patient safety laws. The AOA also described a persistent effort by online vision tests to evade federal oversight and regulation, as well as continued, deceptive marketing tactics that mislead patients and potentially jeopardize their eye and vision health," said Christopher J. Quinn, O.D., president of the AOA.