BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH IOL DELIVERY SYSTEM CARTRIDGE

    MDR report key: 723002 · Received June 2, 2006

    Report

    Report Number
    1119421-2006-00133
    Event Type
    Injury
    Date Received
    June 2, 2006
    Date of Event
    January 26, 2006
    Report Date
    May 4, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A NURSE FROM THE USER FACILITY REPORTED SIX PT 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 FOLLOW-UP, 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 PT. IN THIS CASE, THE ENDOPHTHALMITIS OCCURRED WITHIN THE FIRST 24 HRS FOLLOWING SURGERY. INTRAVITREAL ANTIBIOTICS AND STEROIDS WERE ADMINISTERED. VITREOUS CULTURES WERE NEGATIVE. THE SURGEON REPORTS THE PT HAS AN EXCELLENT PROGNOSIS. THE CARTRIDGE LOT NUMBER USED FOR THIS PT WAS NOT SPECIFIED. THIS IS #1 OF 4 REPORTS BEING SUBMITTED: #1--1119421-2006-00133, #2--1119421-2006-00134, #3--1119421-2006-00135, #4--1119421-2006-00136.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention