BEUDAMED
    FDA Enforcement Class II 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 · Reported May 24, 2017

    Enforcement

    Recall Number
    Z-2096-2017
    Event ID
    77024
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Medical Optics Inc. (AMO)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2017
    Initiation Date
    March 30, 2017
    Classification Date
    May 16, 2017
    Termination Date
    August 23, 2017
    Address
    1700 E Saint Andrew Pl, Santa Ana, CA, 92705-4933, United States

    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.

    Code Info

    Part Number NGP0025 Lot CA06182 (72 units) Part Number NGP0020 Lot CA06180 (288 units)

    Distribution

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

    Quantity

    360 units total