BEUDAMED
    FDA Recall Terminated

    AMO PhacoFlex Il Model SI40NB Intraocular Lenses

    Recall: Z-0267-2007 · Initiated October 31, 2006

    Recall

    Recall Number
    Z-0267-2007
    Event Number
    36905
    Firm
    Advanced Medical Optics, Inc.
    FEI Number
    3003843509
    Product Code
    HQL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 31, 2006
    Posted
    December 14, 2006
    Terminated
    January 13, 2012
    Address
    1700 E Saint Andrew Pl, Santa Ana, CA, 92705-4933

    Description

    AMO PhacoFlex Il Model SI40NB Intraocular Lenses

    Reason

    These specific serial numbers of lenses are being recalled because AMO has received reports of post-implantation cloudiness related to some lenses contained in this grouping.

    Action

    On October 31, 2006, a product notification letter was mailed to all customers in the United States via overnight carrier (Federal Express). Included in this correspondence is a listing of the serial numbers and the quantities of intraocular lenses shipped. This listing will act as your Facsimile Form to be returned to AMO for accountability of the lenses shipped to your facility. AMO will ensure the effectiveness of the recall by using a return facsimile form to capture the status of each of the lenses. AMO will provide updates to the FDA, including all information regarding the recall effectiveness and test results obtained as part of our continuing investigation, as part of the recall progress reports.

    Distribution

    Nationwide

    Quantity

    55