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FDA Orders Recall of Telemedicine Platform for Online Eye Exams

The US Food and Drug Administration's letter to Visibly to stop marketing its mHealth app is the latest in a long battle between the telehealth company and those who feel online vision tests aren't safe.

Source: ThinkStock

By Eric Wicklund

- Visibly has taken its vision-screening mHealth app off the market, following a directive from the US Food and Drug Administration.

Earlier this month, the FDA issued a Class 2 Device Recall for the Chicago-based company, formerly known as Opternative, saying the Visibly Online Refractive Vision Test has not received 510(k) clearance from the agency. The company was reportedly marketing its $35 telehealth service in some 34 states.

Visibly has long been at odds with the American Optometric Association (AOA) and others in the industry who feel that a telemedicine platform isn’t the appropriate venue for vision tests.  In April, the company filed a lawsuit against state officials in Indiana, one of at least 11 states that ban the use of connected health platforms for eye exams. That suit was dismissed earlier this month after the company told the judge it is "unable to devote resources to this lawsuit at this time."

“This case is about a simple choice between new technologies that expand access to care and protectionist legislation designed to boost the profits of established businesses,” Joshua Windham, an attorney for the Institute for Justice, a Libertarian law firm representing the company, had said at the time the suit was filed. “Patients and doctors - not the government - should be in charge of managing their own health care decisions.”

In 2016 the company filed a similar lawsuit against officials in South Carolina. In 2018, U.S. District Court Judge DeAndrea Gist Benjamin threw out the lawsuit, saying the company did not have standing – specifically, the company hadn’t suffered an injury as a result of the law. Visibly and IJ have appealed that decision.

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The FDA’s recent recall order drew praise from AOA officials.

"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," AOA President Barbara L. Horn, OD, said in a press release. "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."  

"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,” former AOA President Christopher J. Quinn, OD, added. “This FDA recall is a clear response to AOA's call to action to protect patients."

The AOA filed its first complaint with the FDA against Visibly (then Opternative) in 2016, saying the company’s online vision tests pose a serious health risk and should require federal approval. The company responded that its mobile app is similar to a visual acuity chart, color-vision tester and medical device data system, which don’t require FDA approval.

In 2017, the FDA issued a warning letter to the company that it was in violation of the Federal Food, Drug and Cosmetic Act (FDCA), and requested the company "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."

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Meanwhile, in 2018 the Federal Trade Commission weighed in on efforts by state officials in Washington to restrict ocular telehealth, siding with companies like Visibly and 1-800-CONTACTS

In an 11-page letter to State Rep. Paul Graves, The FTC argued that the state’s proposed bill would unfairly restrict the consumer’s ability to access eye care services and raise the cost of eyeglasses and contact lenses. It would also, the agency said, mandate a comprehensive eye exam regardless of whether one is needed, and “could override the judgment of a vision care provider who otherwise would have concluded that the standard of care could be met with more limited services, either in-person, or if allowed, by telehealth.”

“By requiring an in-person, comprehensive eye examination for all corrective lens prescriptions, the Bill would restrict the use of innovative telehealth eye care technologies, and also could require examinations that are more extensive and costly than necessary,” the FTC said.

Also in support is Americans for Vision Care Innovation, a collection of more than a dozen advocacy groups, research organizations and online eye care vendors formed in 2018 to “encourage states to adopt legislation allowing vision care telehealth services, including online vision testing and online prescription renewal for glasses and contact lens wearers, and to end restrictions on such services where they exist … (and to)  fight against legislation that would roll back access to online vision care services in the states where it is currently allowed.”

“Online vision care services have the potential to produce significant savings for taxpayers,” Pete Sepp, President of National Taxpayers Union, said in a press release. “State and federal governments pay millions of dollars annually for eye care services for government employees and for Americans who receive benefits under government-funded health insurance and other programs. These costs can be substantially reduced if covered individuals have access to online vision care.”

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