BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 10852761 · Received November 17, 2020

    Report

    Report Number
    3011299751-2020-00329
    Event Type
    Injury
    Date Received
    November 17, 2020
    Date of Event
    February 15, 2018
    Report Date
    November 17, 2020
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: MANSOURI, KAWEH ET AL.. "PROSPECTIVE EVALUATION OF STANDALONE XEN GEL IMPLANT AND COMBINED PHACOEMULSIFICATION-XEN GEL IMPLANT SURGERY: 1-YEAR RESULTS." J GLAUCOMA. 2018 FEB;27(2):140-147. MULTIPLE REQUESTS FOR FURTHER INFORMATION HAVE BEEN MADE. ALLERGAN HAS RECEIVED NO RESPONSE FROM THE AUTHORS. THE EVENT OF HIGH INTRAOCULAR PRESSURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    THE ARTICLE "PROSPECTIVE EVALUATION OF STANDALONE XEN GEL IMPLANT AND COMBINED PHACOEMULSIFICATION-XEN GEL IMPLANT SURGERY: 1-YEAR RESULTS" NOTED THE SERIOUS ADVERSE EVENT OF 37% OF PATIENTS REQUIRED NEEDLING INTERVENTION, BLEB REVISION IN 5 EYES, CHOROIDAL DETACHMENT IN 2 EYES, AND SECOND GLAUCOMA SURGERY IN 9 EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316701 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention