BEUDAMED
    FDA Recall Terminated

    G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy.

    Recall: Z-1710-2009 · Initiated June 30, 2008

    Recall

    Recall Number
    Z-1710-2009
    Event Number
    52453
    Firm
    Volk Optical Inc
    FEI Number
    1000122772
    Product Code
    HKS
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    June 30, 2008
    Posted
    July 21, 2009
    Terminated
    March 9, 2012
    Address
    7893 Enterprise Dr, Mentor, OH, 44060-5309

    Description

    G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy.

    Reason

    The ring of the Gonio lenses distributed was engraved as, 'G4 High Mag Gonio LNF'; however, the engraving should have read simply: 'G4 High Mag Gonio.'

    Action

    Volk Optical Inc. contacted their customers and notified them of affected device via E-mail, letter, and Fax transmittals starting June 30, 2008. The recall notification(s) describes the engraving error and instructs the users on steps to replace the affected product. For further questions, contact Volk Optical Inc. at 1-800-345-8655 extension 443 .

    Distribution

    Worldwide Distribution -- Great Britain, China and the U.S.

    Quantity

    15