BEUDAMED
    FDA Enforcement Class III Terminated

    Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.

    Recall: Z-1685-2015 · Reported June 3, 2015

    Enforcement

    Recall Number
    Z-1685-2015
    Event ID
    71014
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Volk Optical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 3, 2015
    Initiation Date
    February 27, 2015
    Classification Date
    May 28, 2015
    Termination Date
    February 19, 2016
    Address
    7893 Enterprise Dr, Mentor, OH, 44060-5309, United States

    Description

    Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.

    Reason

    Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.

    Code Info

    Model #V25LC, Lot: BE09243

    Distribution

    Worldwide Distribution - US Distribution to the states of : MA and VA., and to the countries of Mexico and Sweden.

    Quantity

    6 units