BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 6064138 · Received October 28, 2016

    Report

    Report Number
    3008772169-2016-00725
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    October 1, 2016
    Report Date
    January 21, 2017
    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
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED IN MODEL #/LOT # AND DEVICE MANUFACTURE DATE. (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. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA.(B)(4).

    Additional Manufacturer Narrative · 1

    NO TECHNICAL SERVICES WERE REQUESTED OR PERFORMED ON THE SYSTEM DUE TO THE REPORTED EVENT. THERE WERE NO IMAGES OF THE OPTICAL COHERENCE TOMOGRAPHY (OCT) SCANS, VIDEO OF THE TREATMENT, PATIENT OCULAR/MEDICAL HISTORY OR SYSTEM SETTINGS PROVIDED FOR REVIEW; HOWEVER, A COMPLAINT INTAKE FORM WAS REVIEWED AND THERE WERE NO INDICATIONS OF POSSIBLE CONTRIBUTING FACTORS. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A BILATERAL CASE OF CORNEAL FLAP THICKNESS BEING THICKER THAN PLANNED. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S RIGHT EYE, AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715590 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other