BEUDAMED
    FDA Recall 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 · Initiated February 27, 2015

    Recall

    Recall Number
    Z-1685-2015
    Event Number
    71014
    Firm
    Volk Optical Inc
    FEI Number
    1000122772
    Product Code
    HJK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 27, 2015
    Posted
    May 28, 2015
    Terminated
    February 19, 2016
    Address
    7893 Enterprise Dr, Mentor, OH, 44060-5309

    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.

    Action

    Volk Optical, Inc, sent an Urgent Medical Device Recall letter dated March 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The Firm requests that you return the device(s) for replacement, at our cost. The recalled device(s) should be returned to Volk with an assigned Return Merchandise Authorization (RMA) number. Please contact Volk as soon as you receive this notification to setup a RMA for your device(s). Please contact Volk at (440) 942-6161 or toll-free at (800) 345-8655 to speak with a Volk RMA Coordinator. To return a recalled device(s) to Volk, please ask Volks RMA Coordinator for the appropriate Volk shipping account number (e.g., FedEx, UPS, etc.).

    Distribution

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

    Quantity

    6 units