AOA Public Health Advisory on the Food and Drug Administration's (FDA) Announcement of the Opternative/Visibly's Online Vision Test Recall
AOA Issues Public Health Advisory on the Food and Drug Administration's (FDA) Announcement of the Opternative/Visibly's Online Vision Test Recall
Deirdre Middleton, 703.837.1347
Federal Enforcement Action: Based on a finding by the FDA, Visibly's (formerly known as Opternative) online vision test has been recalled and is no longer available.
AOA complaint April 4, 2016: "No 510(k) premarket notification has been cleared, no de novo request has been granted, and no Premarket approval for the Opternative device has been approved. Accordingly, the device is a Class III device that is adulterated and misbranded. It should be taken off the market until FDA's Center for Devices and Radiological Health (CDRH) has studied the technology and use of the device, its safety and effectiveness, and the claims that are being made for the device in labeling."
FDA Aug. 9, 2019: "The Visibly Online Refractive Vision Test is being recalled since the firm has not received authorization from FDA to market the product."
What's next?: The AOA has filed a complaint with federal officials related to "Express Exam," an online vision test used by 1-800 Contacts, Inc. Additional FDA review and approval is needed of this device regarding its safety and effectiveness. As with Visibly/Opternative, we will continue to work with federal agencies to protect the eye health of the American public and ensure regulatory requirements intended to protect the public are adhered to and enforced.
What patients need to know: Personalized comprehensive eye examinations by AOA doctors of optometry are an important part of general preventive health care. In addition, changes in refractive status can be an underlying symptom of a number of eye or systemic conditions. Systemic diseases can also be detected through comprehensive eye exams. In fact, 301,000 cases of diabetes were first detected by a doctor of optometry in 2018. Based on AOA's advocacy, other federal agencies also realize the critical value of comprehensive eye care. In 2018, the Centers for Medicare & Medicaid Services noted, "comprehensive eye exams are relatively low-cost interventions and early detection of conditions that can be identified through an eye exam may reduce more costly treatment later."
Patients can find an AOA doctor of optometry in their community at aoa.org/doctor-locator.
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