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 backOpternative 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
In October 2017, the FDA issued a warning letter to the company stating that the online screening violates the Federal Food, Drug, and Cosmetic act because it intended for use to diagnose conditions.
The FDA instructed the company to pull the vision test from its website:
“Our office requests that Opternative, Inc. immediately cease activities that result in the misbranding or adulteration of the On-Line Opternative Eye Examination Mobile Medical App device, such as the commercial distribution of the device through your online website.”
Read the warning letter here.
In December 2018, Opternative rebranded itself as Visibly to better represent the eyecare industry, according to the company.
In a press release, founder and Chief Science Office Steven Lee, OD, said: "We understand that our previous company name, Opternative, carried a negative connotation in the eye care industry and positioned the brand as an existential threat to optometrists. This is why it was important for us to rebrand the company with a name that better represents the partnerships we're building with eye care providers and eyewear retailers in the industry."
Related link: Visibly (formerly Opternative) still the same company
In an Optometry Times guest editorial, Dr. Sonsino cautioned ODs to remind their patients that although the company name had changed, the online refraction offered by Visibly had not.
What is a recall?
Recall is a voluntary action undertaken by a company to remove or correct marketed products that violate laws administered by the FDA.
By contrast, market withdrawl involves a company’s removal or correction of marketed productions in minor violation not subject to legal action by the FDA.
Related link: The underlying concern of online refractions
According to the FDA, recalls fall into three categories to indicate the degree of health hazard posed by the recalled product:
• Class I: reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
• Class II: use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
• Class III: use of, or exposure to, a violative product is not likely to cause adverse health consequences
Visibly’s online refraction screening is a Class II recall.
According to the recall notice, “The Visibly Online Refractive Vision Test is being recalled since the firm has not received authorization from FDA to market the product.”
Read more content by Gretchyn Bailey.