BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUID OPTICS INTERFACE (CATALYS)

    MDR report key: 6861435 · Received September 13, 2017

    Report

    Report Number
    6861435
    Event Type
    Malfunction
    Date Received
    September 13, 2017
    Date of Event
    July 27, 2017
    Report Date
    August 9, 2017
    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

    WE HAVE 4 PRODUCT FAILURES TO REPORT (ALL FROM THE SAME CASE; ALL WITH THE SAME ISSUE). THE LOI CHAMBER WOULD FILL WITH WATER PRIOR TO ALIGNING THE LASER. NONE OF THE 4 HAD PATIENT CONTACT NOR PATIENT HARM. THE PROCEDURE WAS CANCELLED AND SERVICE WAS CALLED ON THE MACHINE. MANUFACTURER RESPONSE FOR LIQUID OPTICS INTERFACE (X4), (BRAND NOT PROVIDED) (PER SITE REPORTER). DISCARDED AT VENDOR DIRECTION - NEW LOI WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642244 LIQUID OPTICS INTERFACE (CATALYS) OPHTHALMIC FEMTOSECOND LASER, LOI OOE ABBOTT MEDICAL OPTICS INC.(AMO) LOI 3269144, 3548295 (X2), 496927

    Patients

    Seq Age Sex Outcome Treatment
    1