BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 11778445 · Received May 5, 2021

    Report

    Report Number
    2028159-2021-00460
    Event Type
    Injury
    Date Received
    May 5, 2021
    Date of Event
    April 13, 2021
    Report Date
    August 10, 2021
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    UDI-DI
    00380659981623
    PMA / PMN Number
    K163551
    Removal / Correction Number
    2016-010
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON QUALITY ASSURANCE (QA) ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. 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 #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 SURGEON REPORTED AN INCOMPLETE SIDE CUT ON A PATIENT¿S LEFT EYE DURING A FLAP CREATION PROCEDURE. THE SURGEON COMPLETED THE SIDE CUT USING A BLADE. THE FLAP WAS LIFTED AND EXCIMER LASER TREATMENT WAS COMPLETED. OPAQUE BUBBLE LAYER WAS NOTICED DURING THE LASER TREATMENT IN THE AREA OF THE INCOMPLETE SIDE CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671517 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention