BEUDAMED
    FDA Enforcement Class III 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 · Reported July 15, 2015

    Enforcement

    Recall Number
    Z-2055-2015
    Event ID
    71048
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Volk Optical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 15, 2015
    Initiation Date
    February 27, 2015
    Classification Date
    July 9, 2015
    Termination Date
    February 4, 2016
    Address
    7893 Enterprise Dr, N/A, Mentor, OH, 44060-5309, United States

    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.

    Code Info

    Model: L90C, Lot: BE03356,

    Distribution

    Distribution to VA only

    Quantity

    78 units