BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VORTEX SURGICAL

    MDR report key: 24078620 · Received January 15, 2026

    Report

    Report Number
    3013002167-2026-00003
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Date of Event
    November 13, 2025
    Report Date
    January 13, 2026
    Manufacturer
    VORTEX SURGICAL INC.
    Product Code
    HQB
    UDI-DI
    00810123483549
    PMA / PMN Number
    K220263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER AN INVESTIGATION WE HAVE DETERMINED THAT SOME TIPS HAVE ABNORMALITIES THAT MAY PREVENT INSERTION INTO A 25GA CANNULA OR PROVIDE RESISTANCE REMOVING THE DEVICE FROM THE CANNULA. PRODUCTION AND QUALITY CONTROL HAVE BEEN MADE AWARE OF THE ISSUE TO HELP PREVENT REOCCURRENCE. DEVICES ARE 100% CHECKED ON CANULA COMPATIBILITY PRIOR TO RELEASE. THE ASSEMBLY LOT 040-2509-288 THAT MAY BE AFFECTED CONTAINING 295 ASSEMBLIES. THESE 295 ASSEMBLIES WERE USED IN ONE FINISHED GOOD STERILE LOT (2509040) CONTAINING 59 BOXES. WE HAVE RECALLED ALL 59 BOXES.

    Description of Event or Problem · 0

    SURGEON HAD DIFFICULTY GETTING VS0135.25 ILLUMINATED FLEX-TIP LASER PROBE TO PASS THROUGH TRANSITION OF THE CANNULA. CANNULA PULLED OUT OF THE EYE. NO PATIENT HARM NOTED BY SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146404 VORTEX SURGICAL OPHTHALMIC ILLUMINATED LASER PROBE HQB VORTEX SURGICAL INC. VS0135.25 2509040 00810123483549

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other