BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 18278432 · Received December 6, 2023

    Report

    Report Number
    3011299751-2023-01007
    Event Type
    Injury
    Date Received
    December 6, 2023
    Date of Event
    November 2, 2023
    Report Date
    December 6, 2023
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    UDI-DI
    01240000000405
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: FRANCO, FABRIZIO, ET AL. ¿¿AIR AND VISCO¿ TECHNIQUE: A PROMISING INNOVATION IN THE SURGICAL IMPLANTATION OF THE XEN GEL STENT DEVICE.¿ VISION, VOL. 7, NO. 4, P. 71. HTTPS://DOI.ORG/10.3390/VISION7040071. 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 EVENT IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    REPORTED EVENTS OF "2 EYES HAD TRANSIENT IOP SPIKES WITHIN POW1; 3 EYES REQUIRED ANTIGLAUCOMA MEDICATION(S); 4 EYES REQUIRED NEEDLING; AND 3 EYES REQUIRED TRABECULECTOMY DUE TO UNCONTROLLED IOP" IN THE UNKNOWN EYE WERE NOTED IN THE ARTICLE: ¿AIR AND VISCO¿ TECHNIQUE: A PROMISING INNOVATION IN THE SURGICAL IMPLANTATION OF THE XEN GEL STENT DEVICE" VISION 7, NO. 4: 71.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364821 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI 01240000000405

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention