BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 1096108 · Received August 1, 2008

    Report

    Report Number
    1119421-2008-00568
    Event Type
    Other
    Date Received
    August 1, 2008
    Date of Event
    June 18, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ALCON MANUFACTURING, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN REC'D FOR EVAL. THE PROD HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PROD MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REC'D IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED BY FAX AND MAIL ON 07/02/2008 AND BY PHONE ON 07/14/2008. A COMPLETED QUESTIONNAIRE HAS NOT BEEN REC'D.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT ONE DAY FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE POSTOPERATIVE AXIS HAD SHIFTED FIFTY DEGREES. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON MANUFACTURING, LTD. / HUNTINGTON SN60T5 10823858

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other