BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 13238530 · Received January 12, 2022

    Report

    Report Number
    3011299751-2022-00007
    Event Type
    Injury
    Date Received
    January 12, 2022
    Date of Event
    December 28, 2021
    Report Date
    January 12, 2022
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: LIABOE, CHASE, AND THOMAS W SAMUELSON. ¿ACUTE IRIS TOXICITY FOLLOWING BILATERAL GEL STENT IMPLANTATION WITH MITOMYCIN-C AND INTRACAMERAL MOXIFLOXACIN JANUARY CONSULTATION #1.¿ JOURNAL OF CATARACT AND REFRACTIVE SURGERY VOL. 48,1 (2022): 125. DOI:10.1097/J.JCRS.0000000000000867. NO FURTHER INFORMATION IS AVAILABLE AS REPORTER HAS DECLINED ADDITIONAL CONTACT. 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 PATIENT UNDERWENT BILATERAL XEN®45 GTS IMPLANT VIA AB-EXTERNO TECHNIQUE. ONE MONTH LATER, PATIENT EXPERIENCED PHOTOPHOBIA, BILATERAL TONIC PUPILS, AND CONCERN FOR EARLY BLEB FAILURE IN THE LEFT EYE. 2 MONTHS AFTER PLACEMENT IN THE LEFT EYE, A BLEB REVISION WITH A MCCANNEL SUTURE IRIS CERCLAGE WAS PERFORMED (IRIS CERCLAGE WAS NOT SUCCESSFUL). BILATERALLY, SLITLAMP EXAMINATION NOTED SEVERE IRIS STROMAL ATROPHY WITH DIFFUSE TRANSILLUMINATION DEFECTS. GONIOSCOPY NOTED DENSELY LAYERED PIGMENT THROUGHOUT THE INFERIOR ANGLE AND TRABECULAR MESHWORK. OPTICAL COHERENCE TOMOGRAPHY OF THE NERVE FIBER LAYER SHOWED THINNING INFERIORLY. HUMPHREY VISUAL FIELD TESTING NOTED DENSE ARCUATE. THE FOLLOWING EVENTS WERE NOTED IN THE ARTICLE: ¿ACUTE IRIS TOXICITY FOLLOWING BILATERAL GEL STENT IMPLANTATION WITH MITOMYCIN-C AND INTRACAMERAL MOXIFLOXACIN JANUARY CONSULTATION #1.¿ JOURNAL OF CATARACT AND REFRACTIVE SURGERY VOL. 48,1 (2022): 125. THIS IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738405 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention