BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PACK

    MDR report key: 25121419 · Received May 8, 2026

    Report

    Report Number
    1644019-2026-02464
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    March 3, 2026
    Report Date
    May 8, 2026
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    00380657524389
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 WAS DEFECTIVE DURING CUTTING; THE CUTTER WAS WEAK PRIOR TO THE INTRAOCULAR LENS IMPLANTATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER THE PRODUCT WAS REPLACED WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223221 CONSTELLATION SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 17MMAY 00380657524389

    Patients

    Seq Age Sex Outcome Treatment
    1