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| AOA President Steven Loomis |
The American Optometric Association (AOA) is hopping mad at eye test app maker Opternative for allegedly marketing its product without proper approvals, and now the group wants the FDA to jump into the fray.
The AOA is urging regulators to take legal action against Opternative for selling a test that leads to an eyeglass or contact lens prescription without an in-person exam by an eye care professional. The product also draws conclusions without taking into account a patient's overarching medical condition, the group said in a statement.
In a complaint submitted to the FDA, the AOA claims that Chicago-based Opternative's test comes with many issues. The product has "significant potential for yielding inaccurate prescriptions." It also "carries a significant risk" of missing serious eye and underlying health problems including glaucoma, hypertension, cataracts and macular degeneration, the AOA said, which "can pose significant health risks to the public."
"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," AOA President Steven Loomis said in a statement.
This is not the first time Opternative has dealt with backlash over its eye test. The State of Michigan recently slapped the company with a cease and desist order for violating the state consumer protection law, the AOA pointed out. And other states are also considering issuing responses to Opternative's product.
But at least for now, Opernative is standing by its test. The company on its website touts results from an "IRB-approved side-by-side clinical trial" that shows that its eye exam is as accurate as a traditional refractive exam performed by an optometrist or ophthalmologist using a phoropter, or common testing device.
- read the statement