BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH IOL DELIVERY SYSTEM CARTRIDGE

    MDR report key: 731199 · Received June 30, 2006

    Report

    Report Number
    1119421-2006-00223
    Event Type
    Injury
    Date Received
    June 30, 2006
    Date of Event
    January 25, 2006
    Report Date
    June 1, 2006
    Manufacturer
    ALCON LABORATORIES, INC. / HUNTINGTON
    Product Code
    KYB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    H.6. EVALUATION CODES ARE FOR COMPLAINT SAMPLES RECEIVED. THIS REPORT WAS MAILED TO THE FDA ON: 06/30/2006. EVALUATION SUMMARY: SEVEN UNOPENED DEVICES WERE RETURNED FROM LOT 950212. THE POUCHES WERE VISUALLY INSPECTED FOR SEAL INTEGRITY AND NO ABNORMALITIES WERE OBSERVED. ALL SEALS REMAINED INTACT. LIMULUS AMEBOCYTE LYSATE (LAL) TESTING WAS CONDUCTED AND ALL SAMPLES MET THE IN-HOUSE LIMIT OF 0.125 EU/ML. NO SAMPLES WERE RECEIVED FROM LOT 944686. THE LOT NUMBER OF THE COMPLAINT PRODUCT USED FOR THIS EVENT WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    A NURSE FROM THE USER FACILITY REPORTED SIX PATIENTS DEVELOPED ENDOPHTHALMITIS OVER A THREE DAY PERIOD. THE DELIVERY SYSTEM CARTRIDGE WAS IDENTIFIED AS A POSSIBLE CONTRIBUTING FACTOR. FOLLOW-UP PROVIDED PATIENT DATA ON FOUR OF THESE PATIENTS AND FOUR MDRS HAVE ALREADY BEEN SUBMITTED. INFORMATION ON TWO MORE PATIENTS WAS RECEIVED SEPARATELY. THIS REPORT IS BEING SUBMITTED AS MANUFACTURER REPORT NUMBER 1119421-2006-00223 (PATIENT #5). THE OTHER MANUFACTURER REPORT NUMBERS ARE: #1 - 1119421-2006-00133, #2 - 1119421-2006-00134, #3 - 1119421-2006-00135, #4 - 1119421-2006-00136, #6 - 1119421-2006-00224. IN THIS CASE THE PATIENT PRESENTED ON POSTOPERATIVE DAY ONE WITH DECREASED VISUAL ACUITY. THE OCULAR EXAM REVEALED MARKED IRITIS, 4+ CELLS IN THE AC AND WBCS ON THE ENDOTHELIUM. THE PATIENT WAS REFERRED TO A RETINAL SPECIALIST. VITREOUS AND AC CULTURES WERE NEGATIVE. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND STEROID INJECTIONS AND HIS SYMPTOMS HAVE RESOLVED. NO FURTHER INTERVENTION IS ANTICIPATED. A NURSE CONSULTANT VISITED THE FACILITY ON 06/13/2006. A NUMBER OF POTENTIAL CAUSES OF TASS WERE IDENTIFIED BY THE FACILITY AND THE CONSULTANT INCLUDING: 1. INADEQUATE CLEANING AND FLUSHING OF PHACO AND I&A HAND PIECES; 2. INADEQUATE RINSING OF INSTRUMENTS FOLLOWING USE OF AN ENZYMATIC CLEANER; 3. MIXING OF ENZYMATIC CLEANER WITHOUT PROPER MEASUREMENT FOR RECOMMENDED CONCENTRATION; 4. INADEQUATE REMOVAL OF VISCOELASTIC FROM INSTRUMENTS; 5. USE OF LIDOCAINE GEL THAT IS NOT PRESERVATIVE FREE; 6. USE OF EPINEPHRINE 1: 1000 CONTAINING BISULFATES; 7. USE OF REUSABLE CANNULAS; 8. INTRAOCULAR INSTRUMENTS LEFT IN INSTRUMENT MILK; AND, 9. RESIDUE FOUND ON NEW OR REPAIRED INSTRUMENTS. PRIOR TO THE CONSULTANT'S VISIT, THE FACILITY HAD ALREADY IMPLEMENTED SEVERAL CHANGES TO ADDRESS POSSIBLE CAUSES OF TASS. CHANGES MADE BY THE FACILITY INCLUDE: 1. PHACO AND I&A HAND PIECES ARE NOW FLUSHED WITH A LEAST 120 CCS OF WATER THROUGH EACH PORT; 2. INSTRUMENTS ARE DOUBLE RINSED; 3. ENZYMATIC CLEANER IS NOW MEASURED OUT TO ENSURE CORRECT CONCENTRATION; AND, 4. DISPOSABLE CANNULAS ARE BEING USED. THE NURSE CONSULTANT MADE THE FOLLOWING ADDITIONAL RECOMMENDATIONS FOR CONSIDERATION: 1) DISCONTINUE THE USE OF ENZYMATIC CLEANERS; 2) USE A SOFT BRISTLED BRUSH TO CLEAN INSTRUMENTS TO BETTER REMOVE VISCOELASTIC, ESPECIALLY FROM HAND PIECES; 3) USE A LIDOCAINE GEL THAT IS PRESERVATIVE FREE; 4) THOROUGHLY RINSE LIDOCAINE GEL FROM THE EYE DURING THE PREP AND AFTER INSERTING THE SPECULUM; 5) USE PRESERVATIVE FREE EPINEPHRINE 1:1000; 6) DISCONTINUE USE "PREMIXSLIP' INSTRUMENT MILK UNLESS IT IS RINSED OFF BEFORE THE INSTRUMENTS ARE STERILIZED; AND, 7) PUT NEW AND REPAIRED INSTRUMENTS THROUGH THE NORMAL CLEANING PROCESS BEFORE PUTTING THEM IN SERVICE. THE WATER QUALITY WAS IDENTIFIED AS ANOTHER POSSIBLE CONCERN. TESTING OF THE WATER WAS RECOMMENDED. ALTHOUGH THE FACILITY DOES NOT USE TAP WATER FOR INSTRUMENT CLEANING, IT DOES FEED INTO THE STERILIZERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONARCH IOL DELIVERY SYSTEM CARTRIDGE LENS GUIDE KYB ALCON LABORATORIES, INC. / HUNTINGTON NA 944686

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention DUOVISC| SA60AT| LIDO GEL 2%| BSS W/EPINEPHRINE