FDA Warns Opternative About its On-Line ‘Eye Exam’ App

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SILVER SPRING, Md.—The FDA recently posted a warning letter sent to Opternative advising the company that its On-Line Opternative Eye Examination Mobile Medical App device does not have the agency’s marketing clearance or approval and is in violation of the Federal Food, Drug and Cosmetic Act. The letter dated Oct. 30, 2017, asks Opternative to submit a premarket submission of information that would allow the FDA to evaluate the app’s safety and effectiveness. It follows a similar notification from FDA that Opternative received on June 15, 2016.

Opternative CEO Brent Rasmussen told VMAIL that the company is “working closely with the FDA” to satisfy its request for information.

Separately, Opternative announced Thursday that it has partnered with a new subscription contact lens company, Sight Supply, and will provide access to online prescription technology on the Sightsupply.com website.

“Providing online vision prescription renewals and updates will help to guarantee our customers have access to affordable, accurate and fast prescriptions,” Anthony Travieso, chief executive officer of Sight Supply, said in the announcement. “Our partnership with Opternative is an exciting opportunity to improve the convenience of our contact lens subscription service by offering vision prescription services online and at the point of sale.”

“Sight Supply is an exciting new addition to our roster of partners, and we look forward to working with them to grow their subscription contact lens service,” Rasmussen noted in the announcement. Sight Supply is a socially-responsible contact lens brand and a partner of See International, a global organization providing vision care to the world’s disadvantaged populations, according to the announcement.