BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 6014127 · Received October 10, 2016

    Report

    Report Number
    3008772169-2016-00674
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Report Date
    December 5, 2016
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    A COMPANY REPRESENTATIVE WENT ON SITE AND EVALUATED THE SYSTEM DUE TO THE REPORTED EVENT. THE REPORTED EVENT WAS UNABLE TO BE REPLICATED. NO SYSTEM ISSUE WAS FOUND THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. SYSTEM WAS FOUND TO MEET SPECIFICATIONS. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE SYSTEM WAS FOUND TO MEET SPECIFICATIONS. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CLINIC EMPLOYEE REPORTED THAT THE OPTICAL COHERENCE TOMOGRAPHY SHIFTED THE IMAGE DOWN INTERMITTENTLY DURING A LASER ASSISTED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667049 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other