BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XEN GLAUCOMA TREATMENT SYSTEM

    MDR report key: 20224412 · Received September 16, 2024

    Report

    Report Number
    20224412
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    June 17, 2024
    Report Date
    July 10, 2024
    Manufacturer
    ALLERGAN SALES, LLC
    Product Code
    KYF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING TRABECULECTOMY PROCEDURE, WHEN IMPLANTING THE XEN GLAUCOMA STENT, DR. [NAME REDACTED] NOTICED THE XEN IMPLANT WAS NOT ENGAGING. HE ATTEMPTED TWICE DIFFERENT IMPLANTS (SN# REDACTED). HE IMPLANTED XEN, [SN# REDACTED] SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441134 XEN GLAUCOMA TREATMENT SYSTEM IMPLANT, EYE VALVE KYF ALLERGAN SALES, LLC 5513-001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown