BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 25021545 · Received April 28, 2026

    Report

    Report Number
    3011299751-2026-00055
    Event Type
    Injury
    Date Received
    April 28, 2026
    Date of Event
    April 15, 2026
    Report Date
    April 28, 2026
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: KIESSLING, DAVID, ET AL. ¿CYSTOID MACULAR EDEMA AS A PREDICTOR FOR BLEB FAILURE AFTER COMBINED XEN45 GEL STENT IMPLANTATION WITH PHACOEMULSIFICATION.¿ GRAEFE¿S ARCHIVE FOR CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY, 15 APR. 2026, HTTPS://DOI.ORG/10.1007/S00417-026-07213-4. 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 ABBVIE IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE EVENT IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    REVIEW OF THE ARTICLE "CYSTOID MACULAR EDEMA AS A PREDICTOR FOR BLEB FAILURE AFTER COMBINED XEN45 GEL STENT IMPLANTATION WITH PHACOEMULSIFICATION" FROM THE JOURNAL GRAEFES ARCHIVE FOR CLINICAL EXPERIMENTAL OPHTHALMOLOGY NOTED THE FOLLOWING POSTOPERATIVE EVENTS "15 EYES HAD CYSTOID MACULAR EDEMA CONFIRMED VIA OPTICAL COHERENCE TOMOGRAPHY (OCT) AND WERE PRIMARILY TREATED WITH MONODEX EYE DROPS FIVE TIMES DAILY, IN 3 EYES MONODEX DID NOT RESOLVE CME AND REQUIRED DIPROSONE 7 MG/ML INJECTION DURING BLEB REVISION; 28 EYES HAD BLEB FAILURE REQUIRING CONJUNCTIVAL REVISION SURGERY (INCLUDING THE CME CASE); UNKNOWN EYES REQUIRED ANTI-GLAUCOMA MEDICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075279 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Unknown Required Intervention