ST. LOUIS—The American Optometric Association escalated its attack against Opternative and its online vision test yesterday by filing a formal complaint with the Food and Drug Administration (FDA) that challenges Opternative’s claims about its product's capabilities, and calls for the FDA to pull the vision test from the market until it can be shown to meet what AOA described as “appropriate Federal requirements for medical devices.”

In filing the detailed complaint, the AOA said Opternative’s test poses “immediate clinical and patient health considerations.” According to the AOA, the Opternative test has “a significant potential for yielding inaccurate prescriptions; is not adequate to safely yield a contact lens prescription; carries a significant risk of the missing of diagnoses of serious eye and general health considerations such as glaucoma, hypertension, cataracts, and macular degeneration; and can pose significant health risks to the public.”

“The AOA—as an authority on quality care and an advocate for our nation's health—is committed to ensuring that the public is not misled, essential care is not diverted or dangerously delayed and patient safety laws are not ignored," remarked AOA president Steven A. Loomis, OD. “No product or company can or should be allowed to operate outside appropriate Federal oversight when vision and overall health are at stake. That’s why the AOA is urging the government to fully enforce basic patient safety and consumer protection safeguards.” 

Responding to AOA’s complaint, Opternative co-founder Aaron Dallek said, “Opternative strongly disagrees with the American Optometric Association’s plea to the FDA to take legal action against the company. The AOA’s claims are false and mischaracterize the proven safety and effectiveness of Opternative’s technology.

“Opternative has a patient satisfaction rate of 99.4 percent, above the optometric industry average for an in-person exam. We are very clear throughout the patient experience that Opternative is not a replacement for an eye health exam. It's on our website, in the exam itself, and is repeated to the patient in any necessary follow up care. We encourage patients to get an eye health exam every two years, and we prohibit patients from taking an Opternative exam more than four consecutive times without certifying that they have received an eye health exam first.”

The AOA has previously appealed to the FDA to examine Opternative’s activities. According to Dr. Loomis, the organization sent a letter to the FDA in fall, 2015 saying that Opternative’s claim that its online vision test is “registered” with FDA falsely implied the agency’s endorsement. AOA has also asked the FDA to look into Opternative’s use of a doctor locator function on its website and its “ambiguous wording.”

Dr. Loomis said the FDA has not responded to the AOA’s concerns.