AOA files expansive FDA complaint against Opternative

April 4, 2016
AOA claims Opternative is in violation of FDCA, urges FDA action.

The absence of any U.S. Food and Drug Administration (FDA) review of Opternative's "vision test" app poses significant health risks to the public, contends AOA in a complaint to the federal agency.

Submitted to the FDA's Office of Compliance, Center for Devices and Radiological Health, on April 4, the complaint argues that Opternative's continued marketing to consumers without federal approval is in violation of the Food, Drug and Cosmetic Act (FDCA). As a result, the device should be taken off the market until such time that the FDA has reviewed the product's claims, safety and efficacy, AOA argues.

Steven A. Loomis, O.D., AOA president, says driving this action is the fact that his patients—and those of other doctors alike—are very worried that personalized, in-person, high-quality health care is increasingly under attack "by corporate equivalents of snake oil salesmen promoting unproven products and shortcuts that lower the bar on quality care standards and put patients at risk."

"Instead of apps or devices of the moment that promise everything but deliver inadequate or incomplete information, Americans want new health care technologies, like those incorporated into my practice and optometry practices across the country, that strengthen the doctor-patient relationship and help make people healthier," Dr. Loomis says. "In this era of rapid health care change, our AOA and state associations are on the leading edge of the fight for very basic patient health and safety standards, and a future in which health care efficiency is based on gains in quality and improved patient outcomes."

Per FDCA requirements, a new device must receive premarket approval (PMA) prior to marketing unless that device has been cleared as substantially equivalent to an already marketed device or has otherwise been determined by FDA not to require a PMA. There is no record this has happened; thus AOA contends the device is being marketed unlawfully. Opternative's apparent position that its app is substantially equivalent to a visual acuity chart, color vision tester and medical device data system ignores the fact that it is very different from those existing devices and also is administered without the involvement of a knowledgeable eye doctor who can detect vision disorders and other diseases in the patient.

Moreover, the fact that the product's inventors filed a patent application in March 2014, "strongly suggests that even Opternative recognizes that its device is not substantially similar to any predicate device." After all, part of a patent application is the claim that something differs from existing technology, AOA notes.

Opternative's "vision test" application relies on a series of self-administered tests, using modified versions of common eye charts—and new charts—displayed on the user's smartphone and computer, to generate a contact lens or eyeglasses prescription. The AOA's assessment of the application determined that some of Opternative's tests not only were used differently than the commonly accepted use, but also some methods and calculations described by the patent application weren't established or customary practices.

In one such instance, Opternative's test for determining myopia or hyperopia correction involves users reading displayed characters at varying distances and identifying a dissimilar character. In another test, Opternative uses a duochrome chart, modified in unconventional ways with red-green split between a cell phone at arms-length and the computer screen at five feet. The patent application states this information can be used to calculate strength of correction, while AOA is not aware of any such accepted methods. The visual acuity chart, though modified by Opternative, measures only visual performance, while the duochrome chart—used in a single plane under strict fogged conditions with room lights controlled to maximize chromatic aberration—is used by an eye doctor to make fine lens power adjustments to a final, predetermined prescription.

The device raises questions about safety and efficacy, including:

  • The potential for inaccurate prescriptions that could harm patients
  • The potential for missed diagnosis of serious eye and general health conditions
  • The creation of a prescription with little meaningful input from an eye doctor

Misleading claims made by "vision tests" that don't involve an eye doctor misinform consumers about the importance of eye health and could delay timely care of potentially sight- and life-threatening diseases, Dr. Loomis says.

"The AOA—as an authority on quality care and a force for public health—actively opposes care backed by scant information that misleads the public and diverts access to essential care," Dr. Loomis says. "There are simply too many questions about the accuracy of this so-called eye exam. That's why the AOA is alerting the public and urging federal and state officials to enforce their statutory and regulatory duties of patient safety and consumer protection safeguards."

Affiliates, AOA continue disputing online "vision tests"

The AOA's complaint is another in a long line of measures to safeguard consumers against misleading and ambiguous claims made by online "vision tests." There are severe pitfalls in separating refractive tests from routine, comprehensive eye exams performed in person by an eye care professional, and this message continues to circulate among government authorities, the media and public.

Only a week earlier, Michigan issued a cease and desist order against Opternative for violating provisions of the state's Eye Care Consumer Protection Law. Through tireless legwork and petitioning by the Michigan Optometric Association (MOA), the state's Department of Licensing and Regulatory Affairs upheld the law that Opternative's "prescriptions" are invalid because the "vision test" consists solely of objective refractive data generated from an automated device, and does not provide a complete ocular health assessment.

"Online vision tests like Opternative are, at best, estimates of consumers' refractive errors; they are not eye examinations in which a patient can be assured that his or her prescription has been accurately validated in person, and more importantly, that his or her eye health has been evaluated by their doctor," Dr. Loomis noted at the time.

This past October, Dr. Loomis approached the FDA for a full investigation of Opternative's misleading claims (member login required), and AOA reported the company's questionable doctor locator function (member login required) that listed doctors of optometry without their knowledge.

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