BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT MEDICAL OPTICS INC. CARTRIDGE

    MDR report key: 6848231 · Received September 7, 2017

    Report

    Report Number
    MW5071990
    Event Type
    Injury
    Date Received
    September 7, 2017
    Date of Event
    August 30, 2017
    Report Date
    September 5, 2017
    Manufacturer
    ABBOTT
    Product Code
    KYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE, IT WAS NOTED THE CARTRIDGE FOR LOADING INNER OCULAR LENS HAS PLASTIC HANGING FROM THE TIP. DEVICE REMOVED FROM FIELD. A SECONDARY DEVICE OPENED AND UTILIZED. ABBOTT MEDICAL REF # 1MTEC30 AMO PUERTO RICO MANUFACTURING, INC., LOT CC06684.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628084 ABBOTT MEDICAL OPTICS INC. CARTRIDGE ABBOTT MEDICAL OPTICS INC. CARTRIDGE KYB ABBOTT REF # IMTEC30 CC06684

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention