BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 1141365 · Received August 22, 2008

    Report

    Report Number
    1119421-2008-00622
    Event Type
    Other
    Date Received
    August 22, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 25, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION; THE DEVICE REMAINS IMPLANTED. 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 BY MAIL AND FAX ON 07/28/2008 AND BY PHONE ON 07/25/2008, 08/04/2008 AND 08/07/2008. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A PT REPORTED SEEING A STREAK OF LIGHT EXTENDING FROM BRIGHT OBJECTS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE OPTHALMIC SURGEON STATED THAT HE DOES NOT THINK THE LENS CONTRIBUTED TO THE REPORTED EVENT, BUT HE IS UNSURE OF THE CAUSE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS MJP ALCON RESEARCH, LTD. / HUNTINGTON SN60T3 10809703

    Patients

    Seq Age Sex Outcome Treatment
    1 Other