BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 8297349 · Received February 1, 2019

    Report

    Report Number
    3011299751-2019-00017
    Event Type
    Injury
    Date Received
    February 1, 2019
    Date of Event
    February 27, 2018
    Report Date
    February 1, 2019
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    KERR, NATHAN, ET AL. "AB INTERNO GEL IMPLANT¿ASSOCIATED BLEB-RELATED INFECTION." THE AMERICAN JOURNAL OF OPHTHALMOLOGY, ELSEVIER INC., VOL. 189, NO. 10, 2018, P.96-101. (B)(4). THE REPORTED EVENTS OF OCULAR PAIN, VISION LOSS, HIGH INTRAOCULAR PRESSURE, EXPOSURE, HYPOPYON, OTHER-MEDICAL AND ENDOPHTHALMITIS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. MULTIPLE REQUESTS FOR FURTHER INFORMATION HAVE BEEN MADE. ALLERGAN HAS RECEIVED NO RESPONSE FROM THE AUTHORS. DEVICE LABELING: THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    REPORTED EVENTS OF EXPOSURE, PAINFUL, DECREASED VISION, DIFFUSE CORNEAL EDEMA, HYPOPYON, 4Þ ANTERIOR CHAMBER CELLS, IOP OF 30 MMHG, AND HYPOPYON IN THE LEFT EYE WERE NOTED IN THE ARTICLE "AB INTERNO GEL IMPLANT¿ASSOCIATED BLEB-RELATED INFECTION." THE AMERICAN JOURNAL OF OPHTHALMOLOGY, ELSEVIER INC., VOL. 189, NO. 10, 2018, P.96-101. THIS RECORD IS FOR THE 2ND CASE. SEE MFR # 3011299751-2019-00021 FOR THE 1ST CASE AND SEE MFR # 3011299751-2019-00018 FOR THE 3RD CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89513 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention