American Optometric Association Complaint Urges FDA Enforcement of Device Standards on Vision "App"
AOA argues that Opternative test can lead to inaccurate prescriptions, and poses serious health risks to the public—and should be removed from the market
ST. LOUIS - The American Optometric Association (AOA) is today asking the Food and Drug Administration to take legal action against an online vision test being marketed by Opternative, Inc. without the type of testing and pre-market approvals frequently required of new medical device technology. The Opternative test produces a prescription for eyeglasses or contact lenses without any examination of the patient by an eye care professional and without taking into account the patient's overall medical condition.
In a detailed complaint now before the FDA, the AOA challenges claims made by Opternative about its product's capabilities, and calls for enforcement action to remove it from the market until it can be shown to meet all appropriate Federal requirements for medical devices under the Food, Drug and Cosmetic Act, including for safety and effectiveness, as determined by Federal officials.
The materials submitted to the FDA also set forth the immediate clinical and patient health considerations that lead the AOA to the conclusion that the Opternative test:
- Has a significant potential for yielding inaccurate prescriptions; and
- Is not adequate to safely yield a contact lens prescription; and
- 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.
Dr. Steven A. Loomis, O.D., AOA president, says the AOA has taken this action to expose questionable product claims, safeguard public health and maintain the medically recognized standard of care linking a patient's vision and eye health.
"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," said Dr. Loomis. "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."
In bringing these issues to the attention of FDA officials and requesting enforcement action on the public's behalf, the AOA notes that the State of Michigan recently issued a cease and desist order against Opternative for violating the state consumer protection law. Other states are considering possible responses to safeguard public health.
A personalized, in person comprehensive eye exam by an eye doctor is the only consistent and clinically proven method to detect not just vision issues, but also a full range of eye and general health conditions; many of which have no obvious signs or symptoms but can threaten vision loss and systemic health. This is because eye exams by doctors of optometry are also effective in diagnosing systemic diseases at an early stage, including diabetes, hypertension and stroke.
About the American Optometric Association (AOA):
The American Optometric Association, a federation of state, student and armed forces optometric associations, was founded in 1898. Today, the AOA is proud to represent the profession of optometry, America's family eye doctors, who take a leading role in an individual's overall eye and vision care, health and well-being. Doctors of optometry (ODs) are the independent primary health care professionals for the eye and have extensive, ongoing training to examine, diagnose, treat and manage disorders, diseases and injuries that affect the eye and visual system, providing two-thirds of primary eye care in the U.S. For information on a variety of eye health and vision topics, and to find a doctor of optometry near you, visit aoa.org.
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