BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 19715229 · Received July 10, 2024

    Report

    Report Number
    3011299751-2024-00101
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    June 14, 2024
    Report Date
    July 10, 2024
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    UDI-DI
    10888628032439
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: LIU A, DHAR L, HUNG S, FELLMAN R, GROVER DS. BRIEF REPORT ON 12-MONTH OUTCOMES OF THE AB INTERNO GEL STENT USING THE INTRAOPERATIVE POST (POSTERIOR SWEEP OF TENONS) TECHNIQUE. OPHTHALMOL GLAUCOMA. 2024 JUN 14:S2589-4196(24)00097-8. DOI: 10.1016/J.OGLA.2024.06.002. EPUB AHEAD OF PRINT. PMID: 38880350. 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

    THE ARTICLE "BRIEF REPORT ON 12-MONTH OUTCOMES OF THE AB INTERNO GEL STENT USING THE INTRAOPERATIVE POST (POSTERIOR SWEEP OF TENONS) TECHNIQUE" FROM THE JOURNAL OPHTHALMOLOGY GLAUCOMA REPORTED THE EVENTS OF "UNKNOWN EYES REQUIRED GLAUCOMA MEDICATIONS; 22 EYES HAD IOP GREATER THAN OR EQUAL TO 21 MMHG; 5 EYES HAD BLOCKAGE OF THE IMPLANT; 8 EYES REQUIRED NEEDLING; 15 EYES REQUIRED ADDITIONAL GLAUCOMA SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363274 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI 10888628032439

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown Required Intervention