BEUDAMED
    FDA Recall Terminated

    Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.

    Recall: Z-2055-2015 · Initiated February 27, 2015

    Recall

    Recall Number
    Z-2055-2015
    Event Number
    71048
    Firm
    Volk Optical Inc
    FEI Number
    1000122772
    Product Code
    HJI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 27, 2015
    Posted
    July 9, 2015
    Terminated
    February 4, 2016
    Address
    7893 Enterprise Dr, Mentor, OH, 44060-5309

    Description

    Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.

    Reason

    Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error.

    Action

    Volk Optical sent a Medical Device Recall letter on March 30, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and quarantine the affected product. If product was further distributed customers need to identify their customers and notify them at once. Customers were instructed to return the affected device for replacement. Customers with questions were instructed to contact Volk at 440-942-6161 or toll free at 800-345-8655. For questions regarding this recall call 440-510-0745.

    Distribution

    Distribution to VA only

    Quantity

    78 units