BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUID OPTIC INTERFACE

    MDR report key: 5834167 · Received July 29, 2016

    Report

    Report Number
    5834167
    Event Type
    Malfunction
    Date Received
    July 29, 2016
    Date of Event
    January 4, 2016
    Report Date
    March 31, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS (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

    LOI VACUUM FAILED. MANUFACTURER RESPONSE FOR LIQUID OPTIC INTERFACE, (BRAND NOT PROVIDED) (PER SITE REPORTER): THE PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    LOI VACUUM FAILED. MANUFACTURER RESPONSE FOR LIQUID OPTIC INTERFACE, (BRAND NOT PROVIDED) (PER SITE REPORTER) :THE PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486340 LIQUID OPTIC INTERFACE OPHTHALMIC FEMTOSECOND LASER OOE ABBOTT MEDICAL OPTICS (AMO) LOI-12 1154683

    Patients

    Seq Age Sex Outcome Treatment
    1