BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PACK

    MDR report key: 25197219 · Received May 18, 2026

    Report

    Report Number
    1644019-2026-02634
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 17, 2026
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    00380657516131
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 OTHER HEALTH CARE PROFESSIONAL REPORTED THAT THE CUTTER WAS POOR CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE PRODUCT WITH NEW CUTTER. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211033 CONSTELLATION SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 1732A3 00380657516131

    Patients

    Seq Age Sex Outcome Treatment
    1