BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 11267794 · Received February 2, 2021

    Report

    Report Number
    3011299751-2021-00010
    Event Type
    Injury
    Date Received
    February 2, 2021
    Date of Event
    December 8, 2020
    Report Date
    February 2, 2021
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: OLSEN, LENE PODER. ¿IMPLANTATION OF THE XEN®45 GEL STENT IN PATIENTS WITH GLAUCOMA AT A UNIVERSITY HOSPITAL ¿ A RETROSPECTIVE QUALITY CONTROL STUDY.¿ ACTA OPHTHALMOLOGICA, LETTER TO THE EDITOR, 08 DECEMBER 2020, E-PUB AHEAD OF PRINT, DOI:10.1111/AOS.14684. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THE EVENT OF SCLERITIS 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

    REPORTED EVENTS OF NECROTIZING SCLERITIS IN THE LEFT EYE WERE NOTED IN THE ARTICLE: ¿IMPLANTATION OF THE XEN®45 GEL STENT IN PATIENTS WITH GLAUCOMA AT A UNIVERSITY HOSPITAL ¿ A RETROSPECTIVE QUALITY CONTROL STUDY,¿ ACTA OPTHALMOLOGICA, E-PUB AHEAD OF PRINT - 8DEC2020. AFTER MONTHS OF TOPICAL BROAD ANTIBIOTICS, SYSTEMIC PREDNISOLONE AND SURGICAL REVISION OF THE NECROSIS AND NECROTIC AREA THEN SUTURING OF PERICARDIAC TISSUE OVER THE THIN SCLERA, AND COVERED WITH CONJUNCTIVA, THE EVENT HAS BEEN RESOLVED. REPORTED EVENTS ARE ASSOCIATED WITH ONE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162120 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) 62031

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention