BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 16228240 · Received January 23, 2023

    Report

    Report Number
    3011299751-2023-00009
    Event Type
    Injury
    Date Received
    January 23, 2023
    Date of Event
    November 10, 2022
    Report Date
    January 23, 2023
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    UDI-DI
    10888628032439
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ARTICLE CITATION: CREAGMILE J, KIM WI, SCOUARNEC C. HYDRUS MICROSTENT IMPLANTATION WITH OMNI SURGICAL SYSTEM AB INTERNO CANALOPLASTY FOR THE MANAGEMENT OF OPEN-ANGLE GLAUCOMA IN PHAKIC PATIENTS REFRACTORY TO MEDICAL THERAPY. AM J OPHTHALMOL CASE REP. 2022 NOV 10;29:101749. DOI: 10.1016/J.AJOC.2022.101749. PMID: 36544749; PMCID: PMC9762144. 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.

    Description of Event or Problem · 0

    REPORTED EVENTS OF "XEN 45 GEL STENT IMPLANTATION THAT FAILED DESPITE BLEB NEEDLING REQUIRING AN AHMED VALVE, WHICH LATER FAILED. THE PATIENT WAS TAKING 4 MEDICATIONS (BRIMONIDINE, DORZOLAMIDE/TIMOLOL, LATANOPROST) WITH AN IOP OF 29 MMHG. THEY THEN UNDERWENT IMPLANTATION OF TWO HYDRUS MICROSTENTS WITH OMNI SURGICAL SYSTEM CANALOPLASTY." WERE NOTED IN THE ARTICLE: HYDRUS MICROSTENT IMPLANTATION WITH OMNI SURGICAL SYSTEM AB INTERNO CANALOPLASTY FOR THE MANAGEMENT OF OPEN-ANGLE GLAUCOMA IN PHAKIC PATIENTS REFRACTORY TO MEDICAL THERAPY. AM J OPHTHALMOL CASE REP. 29:101749. THIS IS THE SAME ARTICLE REPORTED UNDER MDR REPORT # 3011299751-2023-00008 (ALLERGAN COMPLAINT # (B)(4). THIS MDR IS BEING SUBMITTED FOR THE CASE 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484216 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) 5513-001 NI 10888628032439

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention