BEUDAMED
    FDA Adverse Event Death Summary report: N

    KLENZYME

    MDR report key: 453198 · Received April 9, 2003

    Report

    Report Number
    1937531-2003-00001
    Event Type
    Death
    Date Received
    April 9, 2003
    Date of Event
    December 1, 2002
    Report Date
    March 3, 2003
    Manufacturer
    STERIS CORPORATION
    Product Code
    FLG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE 14 CATARACT PATIENTS DEVELOPED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) IN, 2002 AND, 2003 6-24 HOURS POST-SURGICAL PROCEDURE TO REMOVE CATARACTS. TASS CAN BE CAUSED BY CHEMICAL EXPOSURE TO EYE TISSUE. KLENZYME, AN ENZYMATIC CLEANER WAS USE TO CLEAN SURGICAL INSTRUMENTATION, I.E. CATARACT TRAY, FACO HANDPIECE AND INA HANDPIECE. THE INSTRUMENTS WERE ALSO SUBJECTED TO OTHER CHEMICAL CLEANING AGENTS AND CLEANING/STERILIZATION PROCESSES. THE REPORTING FACILITY HAS CONCLUDED THAT IT IS HIGHLY UNLKELY THAT KLENZYME IS THE CAUSE OF OR CONTRIBUTOR TO TASS BUT CANNOT AS YET IRREFUTABLY EXCLUDE KLENZYME AS ANOTHER POTENTIAL SOURCE OF THE PROBLEM. THEY ARE CURRENTLY INVESTIGATING THE WATER QUALITY USED AT THE FACILITY. TESTING OF THE WATER HAS REVEALED AN ELEVATED LEVEL OF MINERALS THAT COULD BE THE CAUSE OR A CONTRIBUTARY FACTOR TO TASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KLENZYME CLEANER, ULTRASONIC, MEDICAL INSTRUMENT FLG STERIS CORPORATION 1673 219693

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention