BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 11689395 · Received April 19, 2021

    Report

    Report Number
    2028159-2021-00383
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    April 1, 2021
    Report Date
    July 12, 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
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS ABLE TO CONFIRM BUT NOT REPLICATE THE REPORTED EVENT. THE INPUT/OUTPUT PRINTED CIRCUIT BOARD (PCB) WAS REPLACED AS A PREVENTATIVE MEASURE. THE COMPANY SERVICE REPRESENTATIVE THEN MONITORED THE SYSTEM THROUGH WARM UP AND A FULL POWER CYCLE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A SERVICE REQUEST (SR) WAS OPENED TO ADDRESS ADDITIONAL EVENTS OF GANTRY UNABLE TO MOVE. THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO CONFIRM OR REPLICATE THE REPORTED EVENT. THE SBRIO PRINTED CIRCUIT BOARD (PCB) WAS REPLACED AS A PREVENTATIVE MEASURE. 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 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 (B)(4) IS NO LONGER OPERATIONAL. LENSX MANUFACTURED PRODUCTS ARE MAINTAINED AND INVESTIGATED BY THE ALCON RESEARCH, LTD. (B)(4). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE REPORTED THE GANTRY IS AUTO DRIVING DOWNWARD. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. NEW INFORMATION RECEIVED REPORTED THE EVENT OCCURRED BEFORE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582805 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1