BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 5094800 · Received September 22, 2015

    Report

    Report Number
    3008772169-2015-00725
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    September 4, 2015
    Report Date
    February 10, 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
    HEALTH PROFESSIONAL

    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. SOFTWARE REVISION 2.3. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. THE SYSTEM HISTORY SHOWS THAT THE LASER WAS VERIFIED SUCCESSFULLY PRIOR TO THE DATE OF TREATMENT. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED AN INCOMPLETE FLAP OCCURRED DURING FLAP CREATION OF A PATIENT'S LEFT EYE. REPORTER INDICATED SUCTION WAS OBTAINED AND SEEMED ADEQUATE; HOWEVER, TOWARD THE END OF THE TREATMENT, DURING THE SIDE CUT, THE SUCTION BEGAN TO DETERIORATE. AFTER PATIENT WAS MOVED TO THE EXCIMER LASER THE INCOMPLETE FLAP AREA WAS NOTICED. THE SURGEON OPTED TO MANUALLY OPEN AN ADDITIONAL SECTION OF THE FLAP, WHICH EXPOSED ENOUGH AREA TO COMPLETE THE EXCIMER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625153 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other