BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1132626 · Received August 22, 2008

    Report

    Report Number
    1119421-2008-00629
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    May 28, 2008
    Report Date
    July 24, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LENS WAS TORN/SPLIT/CRACKED INTO TWO PIECES (POSSIBLY CUT). EACH LENS HALF WAS DIMENSIONALLY EVALUATED USING AN APPROVED TEMPLATE. EACH LENS HALF WAS ACCEPTABLE DIMENSIONALLY; HOWEVER, ONE HAPTIC WAS REJECTABLE VISIBLY FOR COSMETICS. RESULTS FROM THE PROD HISTORY RECORD REVIEW INDICATED THE PROD MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED VIA PHONE ON 07/24/2008 AND 08/07/2008 AND VIA FAX AND MAIL ON 07/25/2008. A COMPLETED QUESTIONNAIRE WAS RECEIVED.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT'S IOL DECENTERED DUE TO HIS EYE ANATOMY. THE IOL WAS REMOVED AND REPLEAD IN A SECOND SURGERY. ADD'L INFO WAS REQUESTED AND RECEIVED. THE SURGEON REPORTED THE PT ALSO EXPERIENCED HALOS SUPERIORLY AS WELL AS POOR NEAR ACUITY. HE REPORTED THE OUTCOME OF THE EVENT FOR THE PT AS "EXCELLENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD3 10750064

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention NORVASC