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Opternative Inc recalls The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a software applicat
Recalled August 14, 2019 · FDA recall Z-2223-2019 · Opternative
Hazard
Lack of 510K clearance · FDA Class II
Units
32
Sold at
Worldwide distribution. US Nationwide distribution in the states of AZ, CA, DE, FL, IL, MO, NV, NY, OH, PA, TX, WA, and UT. Country of Canada.
Description
Lack of 510K clearance
Product
The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a software application that partners and their customers were given access to. Product Usage: This online portion of the Visibly Vision Test Solution is used to measure vision refraction.
Manufacturer(s)
Opternative Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →