BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITREQ

    MDR report key: 24291696 · Received February 9, 2026

    Report

    Report Number
    3012037425-2026-00003
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    January 20, 2026
    Report Date
    February 9, 2026
    Manufacturer
    VITREQ B.V.
    Product Code
    HMX
    UDI-DI
    8719214220815
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    ON JANUARY 26TH, 2026, BVI VITREQ WAS INFORMED ABOUT AN ISSUE CONCERNING OUR PRODUCT, BF25.D01. AS INITIALY STATED BY THE CUSTOMER, THE TIP OF THE CANNULA APPEARED TO BE BROKEN. THE CUSTOMER CONFIRMED THAT THE DEVICE BROKE DURING SURGERY, SPECIFICALLY WHILE IT WAS INSIDE THE PATIENT'S EYE AND THAT THE CAPILLARY FELL INTO THE PATIENT'S EYE AND WAS REMOVED WITH A FORCEPS. FROM THE PHOTOGRAPHIC EVIDENCE RECEIVED, IT COULD BE CONCLUDED THAT THE FRONT CAPILLARY DETACHED FROM THE REINFORCEMENT CAPILLARY. FORTUNATELY, NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355039 VITREQ 25G BLUNT BACKFLUSH INSTRUMENT HMX VITREQ B.V. N/A 20250997 8719214220815

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown