BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS LOI

    MDR report key: 6128564 · Received November 28, 2016

    Report

    Report Number
    6128564
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 18, 2016
    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

    LASER OPTIC INTERFACE LOST SUCTION DURING PROCEDURE X2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780675 CATALYS LOI OPHTHALMIC FEMTOSECOND LASER OOE ABBOTT MEDICAL OPTICS, INC. (AMO) LOI 1403658 & 1220265

    Patients

    Seq Age Sex Outcome Treatment
    1