BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUID OPTICS INTERFACE

    MDR report key: 7424950 · Received April 12, 2018

    Report

    Report Number
    7424950
    Event Type
    Malfunction
    Date Received
    April 12, 2018
    Date of Event
    November 27, 2017
    Report Date
    March 14, 2018
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    OOE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    LOST SUCTION - 1 TIME DURING LASER TREATMENT AND ONE 1 TIME AFTER DOCKING BUT BEFORE LASER STARTED. MANUFACTURER RESPONSE FOR LIQUID OPTICS INTERFACE, (BRAND NOT PROVIDED) (PER SITE REPORTER). ISSUED RGA# AND INSTRUCTED US TO DISCARD PRODUCT. SENT REPLACEMENT DEVICE AT NO CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270118 LIQUID OPTICS INTERFACE OPHTHALMIC FEMTOSECOND LASER OOE OPTIMEDICA CORPORATION 3269146

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR