BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 8656074 · Received May 30, 2019

    Report

    Report Number
    3011299751-2019-00116
    Event Type
    Injury
    Date Received
    May 30, 2019
    Date of Event
    January 1, 2019
    Report Date
    May 30, 2019
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: WOLFS, R.C.W., RAMDAS, W.D. ACTA OPHTHALMOLOGICA, (MARCH 2019) VOL. 97, SUPP. SUPPLEMENT 262, PP. 27. MEETING INFO: ANNUAL CONGRESS OF THE NETHERLANDS OPHTHALMOLOGICAL SOCIETY, NOG 2019. MAASTRICHT, NETHERLANDS. 27 MAR 2019-28 MAR 2019. 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. ADDITIONAL INFORMATION CANNOT BE REQUESTED AS THERE WAS NO CONTACT INFORMATION IN THE ARTICLE. DEVICE LABELING: THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    REPORTED EVENTS OF A REGULAR GLAUCOMA IMPLANT HAS BEEN PLACED IN CONNECTION WITH INADEQUATE EYE PRESSURE REGULATION IN 4 UNKNOWN EYES AND A REVISION OF THE XEN STENT WAS PERFORMED IN 18 UNKNOWN EYES FROM 2015-2018 WERE NOTED IN THE ARTICLE: ¿EVALUATION OF XEN MINIMAL INVASIVE GLAUCOMA SURGERY.¿ ACTA OPHTHALMOLOGICA, 2019, PP. 27.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448187 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention