BEUDAMED
    FDA Recall 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 · Initiated October 25, 2012

    Recall

    Recall Number
    Z-0966-2013
    Event Number
    64410
    Firm
    Volk Optical Inc
    FEI Number
    1000122772
    Product Code
    HJL
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 25, 2012
    Posted
    March 18, 2013
    Terminated
    June 11, 2013
    Address
    7893 Enterprise Dr, Mentor, OH, 44060-5309

    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).

    Action

    Volk sent a Voluntary Medical Device Field Correction letter dated October 25, 2012, to all affected customers. The letter identifed the product, the problem, and the action to be taken by the customer. Customers were asked to correct their records with the correct lot number and to notify their customers of the voluntary field correction and request their compliance in updating their records. For questions customers were instructed to call 440-510-0800 or 440-942-6161. For questions regarding this recall call 440-942-6161.

    Distribution

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

    Quantity

    40 devices