BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 8288678 · Received January 30, 2019

    Report

    Report Number
    3011299751-2019-00015
    Event Type
    Injury
    Date Received
    January 30, 2019
    Date of Event
    August 23, 2018
    Report Date
    January 30, 2019
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OLGUN, ALI, ET AL. ¿ENDOPHTHALMITIS AFTER XEN GEL STENT IMPLANTATION.¿ JOURNAL OF GLAUCOMA, VOL. 27, NO. 12, DECEMBER 2018, P. 191-194. (B)(4). THE REPORTED EVENTS OF ENDOPHTHALMITIS, VISION LOSS, EROSION, OCULAR PAIN, HYPOPYON, INFLAMMATION/IRRITATION, AND VISION ABNORMALITIES ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. MULTIPLE REQUESTS FOR FURTHER INFORMATION HAVE BEEN MADE. ALLERGAN HAS RECEIVED NO RESPONSE FROM THE AUTHORS. DEVICE LABELING: THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    REPORTED EVENTS OF VISUAL ACUITY WAS HAND MOTION, PAIN, REDNESS, EYELIDS AND CONJUNCTIVA WERE HYPEREMIC AND EDEMATOUS WERE DUE TO ENDOPHTHALMITIS, ANTERIOR CHAMBER HAD +3 CELLS AND EXHIBITED HYPOPYON, AND B-SCAN ULTRASONOGRAPHY REVEALED VITREOUS CONDENSATION AND HIGH INTRAOCULAR PRESSURE IN THE RIGHT EYE WERE NOTED IN THE ARTICLE "ENDOPHTHALMITIS AFTER XEN GEL STENT IMPLANTATION." PUBLISHED IN THE JOURNAL OF GLAUCOMA, VOL. 27, NO. 12, 2018, P.191-194. THIS MEDWATCH IS FOR THE 2ND CASE. SEE MFR # 3011299751-2019-00014 FOR THE 1ST CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81849 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention