BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS (AUSTRALIA)

    MDR report key: 14464367 · Received May 20, 2022

    Report

    Report Number
    3011299751-2022-00087
    Event Type
    Injury
    Date Received
    May 20, 2022
    Report Date
    November 8, 2022
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OF "KERATITIS" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE REPORTER HAS DECLINED TO PROVIDE ALLERGAN FURTHER INFORMATION REGARDING EVENT, PRODUCT, AND PATIENT DETAILS.

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: ONG, J., MUKHTAR, A., YU, D., & MORGAN, W. H. "OUTCOMES OF 45 M GELATIN STENT SURGERY OVER 24-MONTH FOLLOW-UP." CLINICAL & EXPERIMENTAL OPHTHALMOLOGY. 2022 OCT 26. HTTPS://DOI.ORG/10.1111/CEO.14181.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED AN UNKNOWN NUMBER OF XEN®45 GTS EVENTS IN UNKNOWN EYE FROM AN UNPUBLISHED LITERATURE ARTICLE DESCRIBED AS "HYPHEMA, DELLEN, HYPOTONY WITH SHALLOW ANTERIOR CHAMBER, HYPOTONY VISCOELASTIC FILL, AND CHOROIDAL EFFUSIONS."

    Description of Event or Problem · 0

    THROUGH AN UPDATED UNPUBLISHED ARTICLE, "THE OUTCOMES OF 45 UM GELATIN STENT SURGERY OVER 24 MONTH FOLLOW-UP," FURTHER REPORTED 111 EYES REQUIRED AT LEAST ONE BLEB NEEDLING, 221 EYES REQUIRED MEDICATION TO REDUCE INTRAOCULAR PRESSURE (IOP), 41 EYES EXPERIENCED HYPHEMA, 8 EYES EXPERIENCED DELLEN, 16 EYES EXPERIENCED HYPOTONY WITH SHALLOW ANTERIOR CHAMBER, 1 EYE EXPERIENCED HYPOTONY WITH VISCOELASTIC FILL, AND 10 EYES EXPERIENCED CHOROIDAL EFFUSIONS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED THE PUBLISHED ARTICLE, "THE OUTCOMES OF 45 UM GELATIN STENT SURGERY OVER 24 MONTH FOLLOW-UP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563566 XEN 45 GTS (AUSTRALIA) IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female