BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 785211 · Received November 17, 2006

    Report

    Report Number
    1119421-2006-00388
    Event Type
    Injury
    Date Received
    November 17, 2006
    Report Date
    October 23, 2006
    Manufacturer
    ALCON LABORATORIES, INC./HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    H3, 6: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN REC'D FOR EVAL. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REC'D FOR THIS LOT NUMBER. ADD'L INFO WAS REQUESTED BY FAX AND BY MAIL ON 11/15/2006. F/U CALLS WERE COMPLETED ON 11/15/2006 AND 11/16/2006. A COMPLETED QUESTIONNAIRE HAS NOT BEEN REC'D TO DATE.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THE INTRAOCULAR LENS WAS IMPLANTED AND REMOVED. A HOLE WAS MADE DURING INSERTION AND THERE WAS VITREOUS LOSS. NO OTHER DETAILS WERE PROVIDED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES, INC./HUNTINGTON SN60AT 992883

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention