After heavy pressure from the American Optometric Association (AOA), the online vision screening test from Visibly (formerly Opternative), is no longer available and has been recalled by the company, according to the U.S. Food & Drug Association (FDA).
The AOA has lobbied the FDA for several years about the online test not undergoing premarket review prior to marketing and not receiving FDA approval for safety and efficacy.
Related link: Eyecare community raises red flags over Opternative
“Visibly has been held acountable for violating the law,” says Barbara L. Horn, OD, AOA president, “and the AOA is grateful to the FDA for addressing the issue we raised back in 2016.”
Says Jeffrey Sonsino, OD, FAAO: “This is a huge win by the incredible efforts day in and day out of the AOA to protect the public from companies who exist solely for profit.”
Dr. Sonsino is in practice in Nashville, TN. He is also an executive board member of the Healthcare Alliance for Patient Safety and past chair of the AOA Contact Lens and Cornea Section.
“This is a huge victory, and we will continue to educate ODs as we evaluate other devices and services,” says Dr. Horn. “This is one more step in making sure that the important doctor-patient relationship will be maintained, as critical as it is.”
Visibly declined comment to Optometry Times about the recall.
Looking back
Opternative launched in 2015 as a tool for patients who may not require a yearly eye exam to obtain a new glasses or contact lens prescription.
Optometrists immediately showed concern about members of the the public misunderstanding the nature of the online vision screening and assuming they had received an ocular health exam.
In April 2016, the AOA filed a complaint with the FDA about Opternative protesting the lack of safety and efficacy approval.
In May 2016, lawmakers in South Carolina overrode a government veto to ban online eye exam technology, joining Georgia and Indiana.
During the summer of 2016, Opternative (at the time) partnered with 1 800 Contacts to offer online vision testing to 1 800 customers interested in renewing their contact lens prescriptions. The vision screening serive was called ExpressExam. The companies renewed their partnership 18 months later. At some point, 1 800 Contacts no longer had a relationship with Opternative by referring to its service as Rx Renewal, LLC
Related link: 1 800 Contacts now offers Opternative refraction to its customers
