BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 9356724 · Received November 21, 2019

    Report

    Report Number
    3011299751-2019-00304
    Event Type
    Injury
    Date Received
    November 21, 2019
    Date of Event
    September 26, 2019
    Report Date
    November 21, 2019
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY DEVIATIONS OR NON-CONFORMANCES ARE FOUND, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THE EVENTS OF INCORRECT PLACEMENT, VISION ABNORMALITIES, AND BLEB RELATED ISSUES ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING THE EVENT, PRODUCT, AND PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL IMPLANTED A XEN IN THE PATIENT'S RIGHT EYE AND THEN NOTED THEY "HAD TO REVISE IT AS IT HAD A TOO POSTERIOR PLACEMENT AND WAS NOT FUNCTIONING". FOLLOWING THIS, IT WAS SITTING ON IRIS IN AC, WITH GOOD HIGH DOME, DIFFUSE BLEB, BUT PATIENT'S VA HAS NOT RECOVERED SINCE OP (6/5 PREOP UA, NOW 6/36, PH 6/9). [PATIENTS] GOT A MYOPIC SHIFT, (-1.00/-0.25 X 174 BCVA 6/5), PATIENT ALSO HAS APPEARANCE OF ASTEROID HYALOSIS TYPE DEPOSITS IN THE VITREOUS, WHICH WAS NOT THERE BEFORE. PATIENT IS PHAKIC AND HAS SOME SYMPTOMS OF BLEB DYSAESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149453 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) 62031

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR