BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 6911946 · Received October 3, 2017

    Report

    Report Number
    3008772169-2017-00512
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 8, 2017
    Report Date
    October 3, 2017
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE VISITED THE SITE AND EVALUATED THE SYSTEM DUE TO THE REPORTED EVENT. FURTHER INVESTIGATION, THE REPRESENTATIVE CONFIRMED THE ROOT CAUSE OF THE GANTRY ISSUE CAN BE ATTRIBUTED TO THE NON-CONFORMING GANTRY MOTOR. TO CORRECT THE ISSUE, THE REPRESENTATIVE VISITED THE SITE TO REPLACE THE GANTRY ASSEMBLY AND THEN TESTED AND VERIFIED THE SYSTEM TO MEET SPECIFICATIONS PRIOR TO DEPARTURE. BASED ON THE RESULTS OF THIS INVESTIGATION, THE REPORTED EVENT WAS CONFIRMED. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO THE NON-CONFORMING GANTRY ASSEMBLY. (B)(4)

    Description of Event or Problem · 1

    A CUSTOMER REPORTED, THE GANTRY DROPPED AFTER THE TECHNICIAN SWITCHED THE KEY OFF. ADDITIONAL INFORMATION RECEIVED; A PATIENT WAS DOCKED AT THE TIME OF THE EVENT. THE LASER WAS REBOOTED, PATIENT WAS RE-DOCKED AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689616 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other