BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 5992699 · Received October 1, 2016

    Report

    Report Number
    3008772169-2016-00666
    Event Type
    Malfunction
    Date Received
    October 1, 2016
    Date of Event
    August 26, 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
    BR
    Reporter Occupation
    NURSE

    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

    ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AT THIS TIME NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. NO TECHNICAL SERVICES WERE REQUESTED OR PERFORMED FOR THE REPORTED EVENT. USER DEFINED SETTINGS COULD BE A POTENTIAL CONTRIBUTOR; HOWEVER, THIS CANNOT BE DETERMINED CONCLUSIVELY. OTHER FACTORS SUCH AS PATIENT MOVEMENT, PATIENT ANATOMY, AND SURGICAL TECHNIQUE COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED DURING A CORNEAL FLAP CREATION THE SURGEON INDICATED HE DID NOT HAVE THE EXPECTED RESULT AND THE PROCEDURE WAS NOT COMPLETED. THE REPORTER HAS INDICATED THE PATIENT WILL RETURN AT A LATER DATE FOR POSSIBLE RETREATMENT.

    Description of Event or Problem · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AT THIS TIME NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644068 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other