BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1180543 · Received September 26, 2008

    Report

    Report Number
    1119421-2008-00758
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    May 1, 2008
    Report Date
    August 27, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE REPORTED COMPLAINT WAS NOT OBSERVED. BOTH HAPTICS WERE BROKEN/TORN IN THE GUSSET AREA (NOT RETURNED). THE OPTIC WAS TORN/SPLIT IN TWO PIECES WITH A CUT-LIKE APPEARANCE. AND OPTICAL INSPECTION COULD NOT BE CONDUCTED DUE TO LENS DAMAGE. WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MFG RELATED. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTATION INDICATES THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 08/29/2008 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 09/19/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT REPORTED DECREASED BCVA AND DOUBLE VISION. THE LENS WAS EXCHANGED FOR A DIFFERENT MODEL. IN A FOLLOW-UP, THE SURGEON REPORTS THE PT IS SEEING GRADUAL IMPROVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD3 10732394

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention