BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 22720054 · Received August 5, 2025

    Report

    Report Number
    3011299751-2025-00095
    Event Type
    Injury
    Date Received
    August 5, 2025
    Date of Event
    July 3, 2025
    Report Date
    August 5, 2025
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    UDI-DI
    10888628032439
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: GARCÍA-BARDERA, J., GARCÍA-FEIJOO, J., MORALES-FERNÁNDEZ, L., & MARTÍNEZ-DE-LA-CASA, J. M. (2025). INNOVATIVE USE OF PRESERFLO MICROSHUNT FOR MANAGING POST-XEN AVASCULAR BLEB IN POSNER-SCHLOSSMAN SYNDROME. CANADIAN JOURNAL OF OPHTHALMOLOGY. JOURNAL CANADIEN D'OPHTALMOLOGIE, S0008-4182(25)00278-9. ADVANCE ONLINE PUBLICATION. HTTPS://DOI.ORG/10.1016/J.JCJO.2025.06.006. MULTIPLE REQUESTS FOR FURTHER INFORMATION HAVE BEEN MADE. ABBVIE HAS RECEIVED NO RESPONSE FROM THE AUTHORS. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ABBVIE IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE EVENTS ARE A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    VIA THE ARTICLE, "INNOVATIVE USE OF PRESERFLO MICROSHUNT FOR MANAGING POST-XEN AVASCULAR BLEB IN POSNER-SCHLOSSMAN SYNDROME" FROM THE CANADIAN JOURNAL OF OPHTHALMOLOGY REPORTED A PATIENT UNDERWENT COMBINED CATARACT SURGERY AND XEN®45 GTS AB INTERNO IMPLANTATION IN RIGHT EYE. POM13, PATIENT PRESENTED WITH SIGNIFICANT AND EXTENSIVE LOSS OF BLEB VASCULARIZATION, IOP OF 33 MMHG WHILE TAKING TIMOLOL, BRIMONIDINE, BRINZOLAMIDE, AND VALACYCLOVIR, AND ADVANCED GLAUCOMATOUS DAMAGE TO VISUAL FIELD. SECONDARY SURGICAL INTERVENTION (SSI) WAS PERFORMED TO IMPLANT A PRESERFLO MICROSHUNT. 10 MONTHS AFTER SSI, PATIENT EXPERIENCED POSNER-SCHLOSSMAN SYNDROME RELATED UVEITIS REQUIRING TREATMENT OF TOPICAL CORTICOSTEROIDS. 12 MONTHS AFTER SSI, IOP WAS 9 MMHG. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2652495 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI 10888628032439

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention