BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCON LABORATORIES, INC.

    MDR report key: 551843 · Received August 23, 2004

    Report

    Report Number
    MW1032997
    Event Type
    Injury
    Date Received
    August 23, 2004
    Date of Event
    July 29, 2004
    Manufacturer
    *
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CATARACT SURGERY IN 2004. WITHIN 24 HOURS THE PT COMPLAINED OF BLURRY VISION AND EYE PAIN WITH SWELLING AND DISCHARGE FROM EYE. TWO DAYS LATER PT HAD VITREA TAP WITH INJECTION OF INTRAVITREAL VANCOMYCIN. FLUID WAS CULTURED AND GREW OUT ENTEROCOCCUS FAECALIS. PT HAD LOST VISION IN EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON LABORATORIES, INC. INTRAOCULAR LENS HQL * SN60AT XXXX

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| S