BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1212774 · Received October 24, 2008

    Report

    Report Number
    1119421-2008-00828
    Event Type
    Other
    Date Received
    October 24, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 24, 2008
    Manufacturer
    ALCON RESEARCH, LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO HAS BEEN REQUESTED. THIS REPORT WAS MAILED TO FDA ON: 10/24/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY THE LENS EJECTED FROM THE CARTRIDGE RAPIDLY, CAUSING THE CAPSULAR BAG TO TEAR. THE SURGEON WAS ABLE TO RETURN THE LENS TO THE CENTER OF THE PUPIL AND DID NOT HAVE TO REMOVE IT. THE DAY AFTER THE SURGERY, VITREOUS WAS NOTED IN THE CAPSULAR BAG. THE SURGEON WILL REMOVE THIS IN A COUPLE OF WEEKS. THE SURGEON ALSO REPORTED THAT THE LENS HAD SCRATCHES ON IT. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON SN60WF 142984

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other