BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 11591282 · Received March 30, 2021

    Report

    Report Number
    2028159-2021-00326
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Date of Event
    March 9, 2021
    Report Date
    June 16, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS EXAMINED AS PART OF A PREVENTIVE MEASURE. THE REPORTED EVENT WAS NOT REPLICATED, NOR CONFIRMED. THE COMPANY REPRESENTATIVE WAS UNABLE TO FIND ANYTHING THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. THE MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. BASED UPON THE INFORMATION OBTAINED, THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

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

    Description of Event or Problem · 1

    A SURGEON REPORTED A SLIGHT TAG AROUND 230 DEGREE AXIS OF THE SIDE CUT IN THE RIGHT EYE DURING FLAP CREATION. THE PROCEDURE WAS COMPLETED USING A FEMTO SPATULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488329 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1