BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ZLB00

    MDR report key: 5090407 · Received September 21, 2015

    Report

    Report Number
    5090407
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    September 8, 2015
    Report Date
    September 11, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS INC
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE LOADING THE INTRAOCULAR LENS, AMO ZLBOO 18.5 DIOPTER, THE TRAILING HAPTIC GOT CURLED UP IN THE CARTRIDGE. THE LENS WAS REMOVED FROM THE FIELD AND THE SURGEON LOADED THE SECOND LENS AND INSERTED IT WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621554 TECNIS ZLB00 INTRAOCULAR LENS HQL ABBOTT MEDICAL OPTICS INC 17.5 DIOPTER

    Patients

    Seq Age Sex Outcome Treatment
    1 NO