BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VORTEX SURGICAL INC

    MDR report key: 23989239 · Received January 7, 2026

    Report

    Report Number
    3013002167-2026-00002
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    December 5, 2025
    Report Date
    January 6, 2026
    Manufacturer
    VORTEX SURGICAL, INC.
    Product Code
    HQB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VORTEX SURGICAL RECEIVED A COMPLAINT FROM OUR KOREAN DISTRIBUTOR ABOUT THE SEAL IN ONE OF OUR STERILE PRODUCT POUCHES. VORTEX INITIATED COMPLAINT 1204 AND REQUESTED RETURN OF THE PRODUCT FOR EXAMINATION. THE RETURNED PRODUCT INCLUDED FOUR INSTANCES OF A SMALL VOID IN THE SEAL FROM THREE DIFFERENT LOTS OF PRODUCT. ROOT CAUSE ANALYSIS DETERMINED THAT THE SEAL FAILURE OBSERVED IN THE FOUR UNITS WAS CAUSED BY AN OPERATOR THAT FAILED TO FOLLOW THE TRAINED SEALING PROCESS. REVIEW OF OUR RECORDS SHOW THAT THE COMPLAINT PRODUCTS WERE PACKAGED AND STERILIZED ON STERILE LOAD 1140 AND 1141 AND WERE RELEASED IN NOVEMBER AND DECEMBER OF 2024. AS A CONTAINMENT ACTION, WE HAVE INSPECTED THE POUCH SEALS OF OUR INVENTORY AND DID NOT FIND THE SAME FAILURE METHOD IN ANY OF THE (B)(4) POUCHES THAT WERE INSPECTED.

    Description of Event or Problem · 0

    VORTEX SURGICAL RECEIVED A COMPLAINT FROM OUR KOREAN DISTRIBUTOR ABOUT THE SEAL IN ONE OF OUR STERILE PRODUCT POUCHES. VORTEX INITIATED COMPLAINT 1204 AND REQUESTED RETURN OF THE PRODUCT FOR EXAMINATION. THE RETURNED PRODUCT INCLUDED FOUR INSTANCES OF A SMALL VOID IN THE SEAL FROM THREE DIFFERENT LOTS OF PRODUCT. ROOT CAUSE ANALYSIS DETERMINED THAT THE SEAL FAILURE OBSERVED IN THE FOUR UNITS WAS CAUSED BY AN OPERATOR THAT FAILED TO FOLLOW THE TRAINED SEALING PROCESS. REVIEW OF OUR RECORDS SHOW THAT THE COMPLAINT PRODUCTS WERE PACKAGED AND STERILIZED ON STERILE LOAD 1140 AND 1141 AND WERE RELEASED IN NOVEMBER AND DECEMBER OF 2024. RECALL HAS BEEN ISSUED FOR ALL ITEMS MANUFACTURED ON STERILE LOADS 1140 AND 1141.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53021 VORTEX SURGICAL INC DISPOSIBLE OPTHALMIC SURGICAL INSTRUMENTS HQB VORTEX SURGICAL, INC. VS0744.25 2410053

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other