BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 8797678 · Received July 17, 2019

    Report

    Report Number
    3011299751-2019-00162
    Event Type
    Injury
    Date Received
    July 17, 2019
    Date of Event
    March 5, 2019
    Report Date
    March 4, 2020
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY DEVIATIONS OR NON-CONFORMANCES ARE FOUND, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION NOTED LEFT EYE VISUAL IS LIGHT PERCEPTION WITH CONJUNCTIVA SEVERELY INFECTED AND DEVICE COULD NOT BE SEEN AT THE PARS PLANA VITRECTOMY. TREATMENT WAS NOTED AS VITRECTOMY WITH ANTIBIOTICS. THE EVENT HAS NOT BEEN RESOLVED.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENTS OF ENDOPHTHALMITIS, BLEBITIS AND VISION LOSS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING THE 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 REPORTED SEVERE ENDOPHTHALMITIS/BLEBITIS ABOUT 9 MONTH POST-OP IN THE LEFT EYE WITH VISION FROM 0,3 TO 1/20 NTV. PATIENT HAS BEEN TREATED WITH EXCISION OF BLEB, PPV (PAR PLANA VITRECTOMY) AND EXPLANTATION OF THE LENS. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591211 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) 62066

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention