FDA Recalls Visibly’s Online Vision Test

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CHICAGO—More than three years after the Food & Drug Administration (FDA) began scrutinizing Visibly’s controversial online refractive vision test, the agency has issued a recall for the test, posing a major threat to Visibly’s venture into ocular telehealth. On August 8, the FDA issued a Class 2 Device Recall for the test. According to the FDA document, “The Visibly Online Refractive Vision Test is being recalled since the firm has not received authorization from FDA to market the product.”

The agency’s authorization process, known as 510k premarket approval, requires a device to be “at least as safe and effective,” or “substantially equivalent” to a legally marketed device that is not subject to FDA premarket approval.

“A recall is a firm's correction or removal of a marketed product that the FDA considers to be in violation of the laws it administers. Recalls occur to reduce a risk to health posed by a device or to remedy a violation of the act caused by a device, which may present a risk to health. The Visibly Online Refractive Vision Test recall meets this criteria,” Keisha Thomas, deputy director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices in FDA’s Center for Devices and Radiological Health told VMAIL.

FDA medical device recalls are usually conducted voluntarily by the manufacturer.

Visibly executives were not available for comment.

As of December, 2018, the Chicago-based company, formerly known as Opternative, was marketing its online vision test in 39 states. However, the company’s recently redesigned website no longer advertises the test, and instead features discounts from eyeglass and contact vendors.

The American Optometric Association has long opposed Visibly’s online vision test, and has taken legal action against the company to prevent the company from offering the test to consumers. In a statement issued yesterday, AOA president Barbara L. Horn, OD praised the FDA’s recall. "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 Horn.

"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."

Visibly has a number of business partners, and it is not yet clear what effect the recall will have on them or on other companies marketing similar tests.

Visibly’s troubles with the FDA began in 2016, when the company, then known as Opternative, received a warning letter from the agency. It received a second warning in October, 2017 as reported by VMAIL.

Visibily CEO Brent Rasmussen told VMAIL in December, 2018 that the company has submitted documentation that the agency has requested and was working toward the agency’s approval for its online eye test.