BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUID OPTICS INTERFACE (CATALYS)

    MDR report key: 6813186 · Received August 23, 2017

    Report

    Report Number
    6813186
    Event Type
    Malfunction
    Date Received
    August 23, 2017
    Date of Event
    July 7, 2017
    Report Date
    July 25, 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

    SUCTION WOULD NOT ENGAGE TO THE PATIENTS EYE OR THE LASER. THE STAFF CONTACTED AMO DURING THE PROCEDURE AND WERE INSTRUCTED TO SHUT DOWN AND REBOOT THE MACHINE AND PROCEED IF THE MACHINE PASSES TESTS. A THIRD LOI-12 WAS USED TO COMPLETE THE PROCEDURE. BOTH FAILED LOIS HAD PATIENT CONTACT BUT NO PATIENT HARM.MANUFACTURER RESPONSE FOR LIQUID OPTICS INTERFACE 12, (BRAND NOT PROVIDED) (PER SITE REPORTER).AMO NO LONGER REQUIRES TO SEND IN FAILED LOIS UNLESS PATIENT INJURY OCCURS. PRODUCT DISCARDED PER VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595933 LIQUID OPTICS INTERFACE (CATALYS) OPHTHALMIC FEMTOSECOND LASER, LOI OOE ABBOTT MEDICAL OPTICS INC.(AMO) LOI-12 4192953 & 4192946

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR