BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PACK

    MDR report key: 24939419 · Received April 21, 2026

    Report

    Report Number
    1644019-2026-02178
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    March 30, 2026
    Report Date
    April 21, 2026
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    00380657524518
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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 HEALTH CARE PROFESSIONAL REPORTED THAT THE CUTTER SUDDENLY WAS NOT FUNCTIONING, BY ALREADY LOWERING THE CUT RATE AND TRIED SHAKING THE CUTTER THRICE WITH THE SAME PAK DURING VIT-RET SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT CONTACT WITH SUSPECT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270589 CONSTELLATION SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 17UC2M 00380657524518

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown