BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 15763417 · Received November 9, 2022

    Report

    Report Number
    3011299751-2022-00189
    Event Type
    Injury
    Date Received
    November 9, 2022
    Date of Event
    September 7, 2022
    Report Date
    November 9, 2022
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    UDI-DI
    10888628032439
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: MCGLUMPHY, E. J., CHAYA, C. J., WIROSTKO, B. M., & JOHNSON, T. V., "THE UTILITY OF HOME TONOMETRY FOR PERI-INTERVENTIONAL DECISION-MAKING IN GLAUCOMA SURGERY: CASE SERIES." AMERICAN JOURNAL OF OPHTHALMOLOGY CASE REPORTS. 28 (7 SEPTEMBER 2022) 101689. HTTPS://DOI.ORG/10.1016/J.AJOC.2022.101689. MULTIPLE REQUESTS FOR FURTHER INFORMATION HAVE BEEN MADE. ALLERGAN HAS RECEIVED NO RESPONSE FROM THE AUTHORS. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE EVENT OF HIGH INTRALOCULAR PRESSURE IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    VIA THE ARTICLE: "THE UTILITY OF HOME TONOMETRY FOR PERI-INTERVENTIONAL DECISION-MAKING IN GLAUCOMA SURGERY: CASE SERIES." AMERICAN JOURNAL OF OPHTHALMOLOGY CASE REPORTS. IT WAS EVENTS OF "XEN GEL STENT IMPLANTATION VIA THE AB EXTERNO TECHNIQUE IN RIGHT EYE, PATIENT LATER EXPERIENCED RECURRENT DISC HEMORRHAGES, A DECLINE IN HUMPHREY VISUAL FIELDS OF -6.0 ± 1.7 DB/YEAR, AND IOP SPIKES INTO THE MID-20S MMHG. 3 MONTHS AFTER PRESENTATION, A TRABECULECTOMY WAS PERFORMED WHICH ACHIEVED A LOWER MEAN IOP OF 9.2 MMHG AND ALL IOP LOWERING DROPS WERE STOPPED." THIS IS THE SAME ARTICLE REPORTED UNDER MDR ID # 3011299751-2022-00190 (ALLERGAN COMPLAINT #PR (B)(4). THIS MDR IS BEING SUBMITTED FOR CASE 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2328244 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) 5513-001 NI 10888628032439

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Disability| R