BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1082571 · Received July 25, 2008

    Report

    Report Number
    1119421-2008-00556
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    January 1, 2008
    Report Date
    June 26, 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
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS AND WAS VERIFIED TO HAVE SIGNS OF HANDLING. BOTH HAPTICS WERE BENT, DUE TO THE POSITION OF THE LENS IN THE CASE. THE OPTIC WAS TORN/SPLIT/CRACKED INTO TWO PIECES. LENS BENCH TESTING COULD NOT BE CONDUCTED, DUE TO THE DAMGE. WHILE WE WERE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATIONS REASONABLY SUGGEST THE DAMAGE IS NOT MANUFACTURING RELATED. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED 06/26/2008, 06/30/2008 AND 07/08/2008. ADDITIONAL INFO WAS RECEIVED 06/26/2008 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED THAT A SURGEON HAD A PT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE LENS WAS EXCHANGED FOR A DIFFERENT DIOPTER OF THE SAME MODEL. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./ HUNTINGTON SN6AD3 10774689

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention