BEUDAMED
    FDA Enforcement Class III Terminated

    Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities

    Recall: Z-1177-2016 · Reported March 23, 2016

    Enforcement

    Recall Number
    Z-1177-2016
    Event ID
    73213
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Volk Optical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 23, 2016
    Initiation Date
    February 2, 2016
    Classification Date
    March 15, 2016
    Termination Date
    April 26, 2017
    Address
    7893 Enterprise Dr, Mentor, OH, 44060-5309, United States

    Description

    Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities

    Reason

    The firm discovered that the incorrect lot number was engraved on the product.

    Code Info

    Model #: VG4SNF, Lot: BE05200

    Distribution

    Worldwide Distribution - US (Virginia only) Internationally to Canada, France & Indonesia.

    Quantity

    9 lens