Medical DeviceAug 14, 2019
Opternative The Visibly Online Refractive Vision Test which is part of the Visibly Vision recall — FDA Z-2223-2019
Lack of 510K clearance
Class IIFDA: OngoingOpternative Inc.
Recall history in this database
Classification mix: Class II: 1.
Understanding this recall history
This page summarizes recall records in which the official source identifies Opternative Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.