BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 17627958 · Received August 25, 2023

    Report

    Report Number
    3011299751-2023-00122
    Event Type
    Injury
    Date Received
    August 25, 2023
    Date of Event
    April 13, 2023
    Report Date
    August 25, 2023
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    UDI-DI
    10888628032439
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED E.1. FACILITY NAME: (B)(6). CONTINUED H.6. HEALTH EFFECT - IMPACT CODE: F2201, F1901. F1903. ARTICLE CITATION: LIN, BENJAMIN R ET AL. ¿ENDOPHTHALMITIS ASSOCIATED WITH XEN STENT IMPLANTATION.¿ AMERICAN JOURNAL OF OPHTHALMOLOGY VOL. 253 (2023): 37-43. DOI:10.1016/J.AJO.2023.04.006 FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. 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 EVENTS ARE KNOWN POTENTIAL ADVERSE EVENTS ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE TITLED ENDOPHTHALMITIS ASSOCIATED WITH XEN STENT IMPLANTATION, HEALTHCARE PROFESSIONAL REPORTED EVENT OF LEFT EYE " PATIENT UNDERWENT XEN45 IMPLANTATION COMBINED WITH CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANTATION IN THE LEFT EYE. PATIENT PRESENTED ON POD246, 2 DAYS AFTER ONSET OF SYMPTOMS (POD244), WITH BCVA OF 20/40, IOP OF 22 MMHG, CONJUNCTIVAL INJECTION, HYPOPYON, CORNEAL EDEMA, AND A SMALL BLEB. NO STENT EXPOSURE / EROSION WAS NOTED. VITREOUS CULTURE RESULTS WERE NEGATIVE. PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS AND RECEIVED INTRAVITREAL INJECTIONS OF VANCOMYCIN/CEFTAZIDIME ON POD246 AND POD248 IN THE LEFT EYE. PPV WAS PERFORMED ON POD248. DEVICE WAS EXPLANTED. AT FINAL FOLLOW UP ON POD344, BCVA WAS 20/200 AND IOP WAS 19 MMHG. THIS IS THE SAME ARTICLE REPORTED UNDER MDR REPORT#: 3011299751-2023-00127 (ABBVIE COMPLAINT#: (B)(4). THIS MDR IS BEING SUBMITTED FOR CASE 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932264 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI 10888628032439

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male Disability| R