BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON INJECTOR MONARCH III D CARTRIDGE

    MDR report key: 1565525 · Received December 22, 2009

    Report

    Report Number
    MW5014108
    Event Type
    Malfunction
    Date Received
    December 22, 2009
    Date of Event
    December 17, 2009
    Report Date
    December 22, 2009
    Manufacturer
    ALCON LABORATORIES
    Product Code
    KYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING AN IOL PROCEDURE, A FOREIGN BODY WAS LEFT IN THE OPERATIVE -RIGHT EYE- OF PT. FOREIGN BODY APPEARED TO BE A WHITE FIBER STRAND OF LUBRIOUS SOLUTION OF DRIED VISCOELASTIC COMING FROM ALCON PRODUCT 8065-9777-63 INJECTOR MARCH III D CARTRIDGE. REMOVAL OF THE IOL OR CONTINUAL MANIPULATION OF THE EYE POSED A RISK TO THE PT'S VISION, THEREFORE, THE PHYSICIAN DECIDED NOT TO REMOVE THE FB. MFR, ALCON LABORATORIES STATED THAT THE DRIED VISCOELASTIC WOULD BREAK DOWN AFTER A FEW DAYS IN THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON INJECTOR MONARCH III D CARTRIDGE INJECTOR MONARCH III D CARTRIDGE KYB ALCON LABORATORIES UNK

    Patients

    Seq Age Sex Outcome Treatment
    1