BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 9076148 · Received September 17, 2019

    Report

    Report Number
    2028159-2019-01688
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Report Date
    September 26, 2019
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K163551
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS ABLE TO CONFIRM THAT THERE WAS A NOISE COMING FROM THE GANTRY, HOWEVER WAS UNABLE TO REPLICATE ANY INTERMITTENT OR UNINTENTIONAL MOVEMENT OF THE GANTRY AS REPORTED. THE COMPANY SERVICE REPRESENTATIVE TESTED THE JOYSTICK AND FOUND THAT THE GANTRY MOVEMENT PERFORMED AS INTENDED WHILE USING THE JOYSTICK ROTATION. THE COMPANY SERVICE REPRESENTATIVE REPLACED THE GANTRY Z MOTOR & BRAKE; HOWEVER, THIS DID NOT RESOLVE THE REPORTED EVENT. THE COMPANY SERVICE REPRESENTATIVE LUBRICATED THE WORM SCREW AND THEN RAN THE GANTRY UP AND DOWN MULTIPLE TIMES TO PROVIDE PROPER LUBRICATION. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE SYSTEM MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED EVENT OF JOYSTICK ISSUES AND UNINTENTIONAL GANTRY MOVEMENT CANNOT BE DETERMINED CONCLUSIVELY, AS THE JOYSTICK AND THE GANTRY'S MOVEMENT WERE FOUND TO MEET SPECIFICATIONS. 2028159-2019-01688-1

    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)). (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN ISSUE WITH THE JOYSTICK WHEN ATTEMPTING TO DOCK. THERE WAS A LOT OF NOISE AND ALMOST DROPPED ON THE PATIENT'S EYE. ADDITIONAL INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872548 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown