BEUDAMED
    FDA Recall Terminated

    Beaver-Visitec International (Beaver-Visitec) BD 1% OVD Sodium Hyaluronate, 10 mg/ml 1.0 mL. Sterile. Rx For Intraocular Use REF 585304 Use as a surgical aid to protect corneal endothelium during cataract extraction procedures, intraocular lens implantation and anterior segment surgery.

    Recall: Z-0606-2011 · Initiated October 4, 2010

    Recall

    Recall Number
    Z-0606-2011
    Event Number
    57104
    Firm
    Becton Dickinson and Company
    FEI Number
    1211998
    Product Code
    LZP
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    October 4, 2010
    Posted
    December 16, 2010
    Terminated
    February 16, 2012
    Address
    411 Waverley Oaks Rd, Ste 2229, Waltham, MA, 02452-8448

    Description

    Beaver-Visitec International (Beaver-Visitec) BD 1% OVD Sodium Hyaluronate, 10 mg/ml 1.0 mL. Sterile. Rx For Intraocular Use REF 585304 Use as a surgical aid to protect corneal endothelium during cataract extraction procedures, intraocular lens implantation and anterior segment surgery.

    Reason

    Finger flange on the BD 1% OVD syringe can disengage during cataract surgery and and may lead to injury.

    Action

    Beaver Visitec issued an Urgent: Field Safety Notice letter, dated 10/4/10 to direct accounts, identifying the affected product and informing users of the potential for the finger grip to disengage during use. The firm offers solutions as follows: Allow the finger grip to remain attached to the syringe and continue to use the product. Position the open side of the finger grip towards the palm to avoid detachment of the grip from the syringe. Remove the finger grip and continue to use the product. Return the unused product to Beaver-Visitec for reimbursement. Users were requested to complete the Customer Response Form. Questions can be directed to: Inside Sales at 781-906-7952.

    Distribution

    Nationwide Distribution

    Quantity

    72278 units