BEUDAMED
    FDA Recall Terminated

    AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use.

    Recall: Z-2096-2017 · Initiated March 30, 2017

    Recall

    Recall Number
    Z-2096-2017
    Event Number
    77024
    Firm
    Abbott Medical Optics Inc. (AMO)
    FEI Number
    3003843509
    Product Code
    MLZ
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    March 30, 2017
    Posted
    May 16, 2017
    Terminated
    August 23, 2017
    Address
    1700 E Saint Andrew Pl, Santa Ana, CA, 92705-4933

    Description

    AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use.

    Reason

    Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package.

    Action

    An Urgent Field Safety notice was sent on 3/30/17 to inform customers that AMO has voluntarily initiated this Action because a possibility exists that, due to a packaging error, 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package. Use of a Vitrectomy Cutter that is a different size than expected could lead to the need to alter the surgical technique, including conjunctival dissection, incision enlargement and scleral sutures.

    Distribution

    Worldwide distribution to SA, TR, AZ, NL, PT, SG, AU, JP, and HK.

    Quantity

    360 units total