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AOA urges FDA to remove Opternative test from the market
The American Optometric Association filed a complaint with the FDA that calls for enforcement action to remove Opternative from the market until it can be shown to meet all appropriate federal requirements for medical devices under the Food, Drug and Cosmetic Act, according to a press release from the association.
The AOA claims that the Opternative test has a significant potential for yielding inaccurate prescriptions and is not adequate to safely yield a contact lens prescription.
The organization also claims the app carries a significant risk of missing diagnoses of serious eye and general health considerations and thus, can pose significant health risks to the public, according to the release.
The AOA also stated that Michigan recently issued a cease and desist order against Opternative for violating the state consumer protection law and that other states are considering possible responses to safeguard public health.