BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 11783598 · Received May 6, 2021

    Report

    Report Number
    2028159-2021-00463
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Report Date
    May 19, 2021
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    UDI-DI
    00380659981623
    PMA / PMN Number
    K163551
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN B.5 AND H.10. H.10.:BASED ON INFORMATION RECEIVED FOLLOWING SUBMISSION OF THE INITIAL REPORT, THIS EVENT DOES NOT MEET CRITERIA FOR REPORTING AS A DEVICE MALFUNCTION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    NEW INFORMATION WAS RECEIVED. GANTRY MOVED TO THE RIGHT BETWEEN CASES.

    Additional Manufacturer Narrative · 1

    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. ALCON LENSX (SITE #3008772169) IS NO LONGER OPERATIONAL. LENSX MANUFACTURED PRODUCTS ARE MAINTAINED AND INVESTIGATED BY THE ALCON RESEARCH, LTD. IRVINE TECHNOLOGY CENTER (SITE #2028159). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED LASER GANTRY MOVED WITHOUT INPUT FROM THE JOYSTICK. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681336 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1