BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH IOL DELIVERY SYSTEM CARTRIDGE

    MDR report key: 1378399 · Received June 2, 2006

    Report

    Report Number
    1119421-2006-00135
    Event Type
    Malfunction
    Date Received
    June 2, 2006
    Date of Event
    January 26, 2006
    Report Date
    May 4, 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, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA FOR # 1 OF 2 LOT NUMBERS IDENTIFIED: CATALOG # 8065977759. LOT # 944686. EXPIRATION DATE - 10/31/2008. MFG DATE: 12/08/2005. DATA FOR # 2 OF 2 LOT NUMBERS IDENTIFIED: CATALOG # 8065977759. LOT # 950212. EXPIRATION DATE: 11/31/2008. MFG DATE - 01/05/2006. EVAL 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. STERILIZATION RECORDS WERE REVIEWED FOR BOTH LOT NUMBERS PROVIDED AND THE STERILIZATION CYCLES RAN WITHIN ALL REQUIRED PARAMETERS WITH NO ANOMALIES. PRODUCT HISTORY RECORDS WERE REVIEWED FOR BOTH LOT NUMBERS PROVIDED AND ALL DOCUMENTATION INDICATES THE PRODUCT MET RELEASE CRITERIA. THE REPORTS FOR THIS FACILITY ARE THE ONLY COMPLAINTS THAT HAVE BEEN RECEIVED FOR THESE LOTS. THE MFR'S INTERNAL. THIS REPORT WAS MAILED TO THE FDA ON: 06/02/2006.

    Description of Event or Problem · 1

    A NURSE FROM THE USER FACILITY REPORTED SIX PTS DEVELOPED ENDOPHTHALMITIS OVER A THREE DAY PERIOD. THREE DIFFERENT SURGEONS WERE INVOLVED. LOT NUMBERS FOR PRODUCT BEING USED WERE PROVIDED AS PART OF THE FACILITY INVESTIGATION. TWO DELIVERY SYSTEM CARTRIDGE LOTS WERE IDENTIFIED. NO PT DATA WAS SUPPLIED. DURING F/U, THE NURSE STATED SHE BELIEVED THE DELIVERY SYSTEM CARTRIDGES MAY HAVE CONTRIBUTED TO THE REPORTED CASES OF ENDOPHTHALMITIS. PT DATA WAS PROVIDED FOR ONLY 4 OF THE 6 PTS. IN THIS CASE, THE ENDOPHTHALMITIS OCCURRED IN THE FIRST 24 HRS FOLLOWING SURGERY. THE PT WAS TREATED WITH PRED FORTE 1% DROPS AND THE SURGEON REPORTS THE PT HAS AN EXCELLENT PROGNOSIS. NO SURGICAL INTERVENTION WAS REQUIRED AND NO CULTURES OBTAINED. THE CARTRIDGE LOT NUMBER USED FOR THIS PT WAS NOT SPECIFIED. THIS IS # 3 OF 4 REPORTS BEING SUBMITTED: 1119421-2006-00133, 1119421-2006-00134; 1119421-2006-00136.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other DUOVISC| SA60AT| BSS W/EPI| TOPICAL TIMOLOL 1/2%| PILOCARPINE 2%