AOA Files Expansive FDA Complaint Against Opternative

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

Submitted to the FDA on April 4, the complaint (member login required) argues that Opternative’s continued marketing to consumers without federal approval is in violation of the Food, Drug and Cosmetic Act (FDCA), and as a result, should be taken off the market until the FDA can review the product’s claims and safety.

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;
• 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.

COA and AOA are consulting their attorneys about legal options.

If you have any questions or comments, please feel free to contact Kristine Shultz, COA government affairs director, at (916) 266-5027.