BEUDAMED
    FDA Recall Open, Classified

    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.

    Recall: Z-2223-2019 · Initiated May 20, 2019

    Recall

    Recall Number
    Z-2223-2019
    Event Number
    83298
    Firm
    Opternative Inc
    FEI Number
    3011276494
    Product Code
    OUG
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    May 20, 2019
    Address
    1 N State St, Ste 1500, Chicago, IL, 60602-3206

    Description

    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.

    Reason

    Lack of 510K clearance

    Action

    The Visibly Online Refractive Vision Test is being recalled since the firm has not received authorization from FDA to market the product.

    Distribution

    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.

    Quantity

    32