BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS LOI

    MDR report key: 6166662 · Received December 12, 2016

    Report

    Report Number
    6166662
    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

    WHEN INITIALLY ATTACHING THE LOI TO THE LASER MACHINE, IT WAS NOTED THAT ONE END OF THE TUBING LINE HAD BEEN BROKEN OFF FROM THE SAFETY RESERVOIR. NO PATIENT CONTACT; SWITCHED TO A NEW LOI TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817826 CATALYS LOI OPHTHALMIC FEMTOSECOND LASER OOE ABBOTT MEDICAL OPTICS INC. (AMO) LOI-12 1826548

    Patients

    Seq Age Sex Outcome Treatment
    1