BEUDAMED
    FDA Enforcement Class III Terminated

    20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.

    Recall: Z-0966-2013 · Reported March 27, 2013

    Enforcement

    Recall Number
    Z-0966-2013
    Event ID
    64410
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Volk Optical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 27, 2013
    Initiation Date
    October 25, 2012
    Classification Date
    March 18, 2013
    Termination Date
    June 11, 2013
    Address
    7893 Enterprise Dr, N/A, Mentor, OH, 44060-5309, United States

    Description

    20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.

    Reason

    The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed up device engraving of V20LC (lot # BB09213) with that from V60C (lot # BB09205).

    Code Info

    Product Code: V20LC; Lot/Serial Numbers: BB09213 & BB09205

    Distribution

    Worldwide Distribution - USA including the states of AZ, CA, GA, MN, NJ, and NM. Internationally to Japan.

    Quantity

    40 devices