The Visibly Online Refractive Vision Test has been recalled by the U.S. Food and Drug Administration.
The test by Visibly, formerly known as Opternative, “is being recalled since the firm has not received authorization from FDA to market the product,” according to a notice from the FDA.
The FDA states that the test has had worldwide distribution, including including Arizona, California, Delaware, Florida, Illinois, Missouri, Nevada, New York, Ohio, Pennsylvania, Texas, Washington and Utah.
Healio.com notes that the FDA sent a warning letter to Opternative in 2017. The news site reports that the company did not respond to a request for comment on the recall.
The American Optometric Association states that in April 2016, it “issued a formal complaint to the FDA that emphasized Opternative’s lack of premarket approval (PMA) prior to marketing. The organization says it “indicated that the test should be removed from the market altogether.”
AOA states that it had concerns about “the potential for inaccurate prescriptions, missed diagnoses of serious and general health conditions, and the creation of a prescription with little input from an eye doctor.”
“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,” said AOA President Barbara L. Horn, OD. “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 action is a Class 2 recall, meaning the FDA considers it “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
The FDA explains that recall is “a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.”