BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUID OPTICS INTERFACE (CATALYS)

    MDR report key: 6813232 · Received August 23, 2017

    Report

    Report Number
    6813232
    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

    PATIENT WAS POSITIONED AND WE BEGAN THE PROCESS FOR THE CATALYS EYE LASER PROCEDURE. SUCTION WAS LOST AND FLUID SUCKED BACK INTO THE RESERVOIR. THE FAILED PRODUCT HAD PATIENT CONTACT BUT NO PATIENT HARM. A NEW LOI-12 WAS USED TO COMPLETE THE PROCEDURE. MANUFACTURER RESPONSE FOR LIQUID OPTICS INTERFACE 12, (BRAND NOT PROVIDED) (PER SITE REPORTER). AMO SENDS REPLACEMENT PRODUCT - NO LONGER REQUIRES RETURNS OF LOIS UNLESS INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594764 LIQUID OPTICS INTERFACE (CATALYS) OPHTHALMIC FEMTOSECOND LASER, LOI OOE ABBOTT MEDICAL OPTICS INC. (AMO) LOI-12 4192953

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR