BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 5075128 · Received September 14, 2015

    Report

    Report Number
    3008772169-2015-00711
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Date of Event
    August 21, 2015
    Report Date
    January 12, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO SAMPLE IS EXPECTED FOR EVALUATION. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND. THE ASSOCIATED DEVICE WAS RELEASED BASED ON THE MANUFACTURER'S ACCEPTANCE CRITERIA. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING CREATION OF THE CORNEAL FLAP IN THE PATIENT'S RIGHT EYE, THE SYSTEM DISPLAYED AN ERROR MESSAGE (Y2 SCANNER ERROR). JUST AS THE SURGEON CLEARED THE ERROR, THE SUCTION WAS PARTIALLY, THEN MOSTLY LOST. UPON ATTEMPTING TO REGAIN THE SUCTION, A SUCKING SOUND WAS HEARD, AND THE SUCTION WAS ENTIRELY LOST. THE CASE WAS ABORTED. THE SURGEON COMPLETED THE FLAP ON THE PATIENT'S LEFT EYE WITHOUT ANY DIFFICULTY. IN A FOLLOW UP, THE SURGEON REPORTED THAT THE PATIENT WAS SCHEDULED TO RETURN FOR TREATMENT COMPLETION WITHIN A FEW DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605775 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other