BEUDAMED
    FDA Recall Terminated

    Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal ophthalmic surgical procedures.

    Recall: Z-1673-2009 · Initiated January 23, 2009

    Recall

    Recall Number
    Z-1673-2009
    Event Number
    52461
    Firm
    Volk Optical Inc
    FEI Number
    1000122772
    Product Code
    KYB
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    January 23, 2009
    Posted
    July 14, 2009
    Terminated
    April 12, 2012
    Address
    7893 Enterprise Dr, Mentor, OH, 44060-5309

    Description

    Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal ophthalmic surgical procedures.

    Reason

    Lens may fall onto eye surface during procedure. Ophthalmologic device had a loose set screw on the Ball-Seal bushing assembly. As a result, the set screw becomes disengaged from the set screw groove in the bushing assembly and the Lens Positioning Unit slides downward.

    Action

    Volk Optical sent a 'MEDICAL DEVICE RECALL' letter to their sole customer on 1/23/2009. The letter requests the return of the remaining two (2) units in the customer's possession (this firm experienced the device failure and reported the consumer complaint which prompted the recall; and had already returned the affected unit to the Volk for refund or replacement). The letter provides Volk's Fedex and UPS numbers for the customer to use to return the recalled units and also provides the E-mail address for the firm's contact person concerning this recall should additional assistance be required.

    Distribution

    USA distribution to a single customer located in MO.

    Quantity

    3 units