BEUDAMED
    FDA Recall Terminated

    Opthalmic microsurgical system-AMO WHITESTAR SIGNATURE Phacoemulsification System, Product Number NGP680300. The device is a modular ophthalmic microsurgical system that facilitates both anterior segment (i.e., cataract) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.

    Recall: Z-1702-2008 · Initiated April 2, 2008

    Recall

    Recall Number
    Z-1702-2008
    Event Number
    47908
    Firm
    Advanced Medical Optics, Inc.
    FEI Number
    3003843509
    Product Code
    HQC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 2, 2008
    Posted
    August 25, 2008
    Terminated
    January 21, 2010
    Address
    1700 E Saint Andrew Pl, Santa Ana, CA, 92705-4933

    Description

    Opthalmic microsurgical system-AMO WHITESTAR SIGNATURE Phacoemulsification System, Product Number NGP680300. The device is a modular ophthalmic microsurgical system that facilitates both anterior segment (i.e., cataract) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.

    Reason

    AMO initiated this field correction event after becoming aware of a trend in complaints associated with AMO Vitrectomy Cutter used in conjunction with the AMO WHITESTAR SIGNATURE Phacoemulsification System. The physician may be unable to make a cut during cataract surgery.

    Action

    On April 2, 2008, AMO began distribution of an Urgent Safety Notice to all customers in the United States via overnight carrier (Federal Express). The U.S safety notice was used as a template for all global AMO communications regarding the Urgent Safety Notice , many of which required translation into local language prior to distribution. Included in this correspondence is a listing of the serial numbers of the affected products. The Notice informed customers of the problem and gave the customers modifications to the Vitrectomy Cutter Priming Instructions. In addition, the notice informed the customers that an AMO Field Service Engineer will be scheduling a site visit to modify a pressure setting on the AMO Whitestar Signature system. Contact the AMO Phaco Technical support at 1-877-AMO-4LIFE for assistance. AMO will provide updates to the FDA, including all information regarding the recall effectiveness as part of the recall progress reports.

    Distribution

    Nationwide and to: AL, AR, CA, CO, FL, HI, IL, IN, MD, NC, ND, NJ, NY, OH, OR, PA, PR, SC, TX & WA and worldwide to: Azerbaijan, Belgium, Germany, Denmark, Egypt, Spain, France, Great Britain, Croatia, Hungary, Israel, Italy, Jordan, Kuwait, Lebanon, Liechtenstein, Netherlands, Norway, Poland, Portugal, Saudia Arabia, Sweden, Turkey, South Africa, Australia, India, New Zealand and Singapore

    Quantity

    191 units