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FDA recalls Visibly online refraction test
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The FDA issued a class 2 device recall for the Visibly Online Refraction Test because “the firm has not received authorization from FDA to market the product,” the agency stated.
The test is distributed worldwide, including Arizona, California, Delaware, Florida, Illinois, Missouri, Nevada, New York, Ohio, Pennsylvania, Texas, Washington and Utah, according to the FDA’s announcement, dated Aug. 8.
The American Optometric Association announced that it issued a formal complaint to the FDA in April 2016 “that emphasized Opternative’s [former name of Visibly] lack of premarket approval prior to marketing,” and urged that the test be removed from the market.
The FDA issued a warning letter to the company in late 2017.
Visibly did not reply to requests for comments from PCON.
The FDA explains on its website that it “uses the term ‘recall’ when a manufacturer takes a correction or removal action to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health or when it is both defective and a risk to health.”
The agency noted that a class 2 recall is defined as: “A situation where a product may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death.”
The FDA further clarified that “a medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted or fixed.”
The AOA stated that for more than 3 years it has “raised concerns about the product’s safety and efficacy, including 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.”
AOA President Barbara L. Horn, OD, commented in the announcement: "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,” and “they must also comply with the law.” – by Nancy Hemphill, ELS, FAAO
Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=174633.