BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 16127091 · Received January 9, 2023

    Report

    Report Number
    3011299751-2023-00002
    Event Type
    Injury
    Date Received
    January 9, 2023
    Date of Event
    October 28, 2022
    Report Date
    January 9, 2023
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    UDI-DI
    10888628032439
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ARTICLE CITATION: YANG SA, CIOCIOLA EC, MITCHELL W, HALL N, LORCH AC, MILLER JW, FRIEDMAN DS, BOLAND MV, ELZE T, ZEBARDAST N; IRIS® REGISTRY ANALYTIC CENTER CONSORTIUM. EFFECTIVENESS OF MICROINVASIVE GLAUCOMA SURGERY IN THE UNITED STATES: INTELLIGENT RESEARCH IN SIGHT REGISTRY ANALYSIS 2013-2019. OPHTHALMOLOGY. 2022 OCT 29:S0161-6420(22)00853-3. DOI: 10.1016/J.OPHTHA.2022.10.021. EPUB AHEAD OF PRINT. PMID: 36522820. MULTIPLE REQUESTS FOR FURTHER INFORMATION HAVE BEEN MADE. ALLERGAN HAS RECEIVED NO RESPONSE FROM THE AUTHORS. THE EVENT 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 · 0

    REPORTED EVENTS OF "CHANGE IN VISUAL ACUITY OF +0.1 LOGMAR FROM BASELINE (ABOUT A 33% DECREASE) IN UNKNOWN EYES; 1491 EYES REQUIRED REOPERATION (MAJORITY OF REOPERATIONS WERE TRABECULECTOMY OR GLAUCOMA DRAINAGE DEVICE IMPLANTATIONS); HYPHEMA IN 25 EYES; CORNEAL EDEMA IN 13 EYES; IRIDOCYCLITIS IN 7 EYES; VITREOUS HEMORRHAGE IN 11 EYES (NO RETINAL DETACHMENTS WERE NOTED); CHOROIDAL HEMORRHAGE IN 4 EYES; ENDOPHTHALMITIS IN 6 EYES; MACULAR EDEMA IN 7 EYES" WERE NOTED IN THE ARTICLE: EFFECTIVENESS OF MICROINVASIVE GLAUCOMA SURGERY IN THE UNITED STATES: INTELLIGENT RESEARCH IN SIGHT REGISTRY ANALYSIS 2013-2019. OPHTHALMOLOGY. (B)(6) 2022; EPUB AHEAD OF PRINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260377 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) 5513-001 NI 10888628032439

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention