BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 22187920 · Received June 11, 2025

    Report

    Report Number
    3011299751-2025-00076
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    May 19, 2025
    Report Date
    June 11, 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: BERTOLANI, Y., RIGO-QUERA, J., SÁNCHEZ-VELA, L., PUJOL-CARRERAS, O., AMILBURU, M., DOU, A., & CASTANY, M. (2025). EFFICACY AND SAFETY OF OPEN-CONJUNCTIVA AB EXTERNO 63 M VS. 45 M XEN® GEL STENT IN GLAUCOMA SURGERY: ONE-YEAR FOLLOW-UP. JOURNAL OF CLINICAL MEDICINE, 14(10), 3545. HTTPS://DOI.ORG/10.3390/JCM14103545. MULTIPLE REQUESTS FOR FURTHER INFORMATION HAVE BEEN MADE. ABBVIE HAS RECEIVED NO RESPONSE FROM THE AUTHORS. THE EVENT OF HIGH INTRAOCULAR PRESSURE IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    REVIEW OF THE ARTICLE "EFFICACY AND SAFETY OF OPEN-CONJUNCTIVA AB EXTERNO 63 M VS. 45 M XEN® GEL STENT IN GLAUCOMA SURGERY: ONE-YEAR FOLLOW-UP" FROM THE JOURNAL OF CLINICAL MEDICINE NOTED THE FOLLOWING EVENTS "0.39 ANTIHYPERTENSIVE DRUGS ON AVERAGE WERE REQUIRED; NEEDLING PROCEDURE REQUIRED IN 5 EYES; 2 EYES REQUIRED SURGICAL BLEB REVISION DUE TO FIBROSIS; 3 EYES REQUIRED SECONDARY GLAUCOMA PROCEDURE TO ACHIEVE OPTIMAL IOP CONTROL; 2 EYES HAD SELF-LIMITED HYPHEMA; 1 EYE HAD WOUND LEAK TREATED WITH A CONTACT LENS; 1 EYE HAD ANTERIOR SEGMENT SYNDROME (TASS) WITH IOP SPIKE, URRETZ-ZAVALIA SYNDROME AND CORNEAL DECOMPENSATION REQUIRING DESCEMET STRIPPING AUTOMATED ENDOTHELIAL KERATOPLASTY (DSAEK) AND TRABECULECTOMY; 8 EYES HAD HYPOTONY; 1 EYE HAD SEROUS CHOROIDAL DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87665 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI 10888628032439

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention