BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNITY TOTAL PLUS COMBINED PROCEDURE PACK

    MDR report key: 25065034 · Received May 4, 2026

    Report

    Report Number
    1644019-2026-02369
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Report Date
    May 4, 2026
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    00380650004840
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NON-HEALTH CARE PROFESSIONAL REPORTED THAT THE CUTTER FAILED TO CUT AT AN UNKNOWN TIMING OF SURGERY. THE PROCEDURAL TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE CUTTER. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31043 UNITY TOTAL PLUS COMBINED PROCEDURE PACK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 17J16M 00380650004840

    Patients

    Seq Age Sex Outcome Treatment
    1