BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS LOI

    MDR report key: 6166515 · Received December 12, 2016

    Report

    Report Number
    6166515
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 25, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS, INC. (AMO)
    Product Code
    OOE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER DOCKING THE PATIENT TO THE LASER MACHINE, THE LOI LOST SUCTION AND FLUID WAS MOVING UP THE TUBING TOWARD THE LASER INPUT VALVE/CONNECTION. PRODUCT HAS PATIENT CONTACT BUT NO PATIENT HARM. NEW LOI WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818265 CATALYS LOI OPHTHALMIC FEMTOSECOND LASER OOE ABBOTT MEDICAL OPTICS, INC. (AMO) LOI-12 1826548

    Patients

    Seq Age Sex Outcome Treatment
    1