BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS (AUSTRALIA)

    MDR report key: 9880145 · Received March 25, 2020

    Report

    Report Number
    3011299751-2020-00144
    Event Type
    Injury
    Date Received
    March 25, 2020
    Date of Event
    February 20, 2020
    Report Date
    March 25, 2020
    Manufacturer
    ALLERGAN (AUSTIN)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF HIGH INTRAOCULAR PRESSURE, CONJUNCTIVAL HEMORRHAGE, GEL STENT FRACTURE AND VISION LOSS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A XEN 45 GEL STENT PATIENT WAS IMPLANTED IN THE LEFT EYE. PATIENT WAS NPL AND THE XEN DEVICE "APPEARS TO HAVE BROKEN" AND THE IOP OF THE EYE REMAINS AT 42 WITH BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342337 XEN 45 GTS (AUSTRALIA) IMPLANT, EYE VALVE KYF ALLERGAN (AUSTIN) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention