BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 5034347 · Received August 27, 2015

    Report

    Report Number
    3008772169-2015-00664
    Event Type
    Malfunction
    Date Received
    August 27, 2015
    Date of Event
    July 30, 2015
    Report Date
    November 30, 2015
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE SYSTEM WAS EXAMINED AND THE REPORTED EVENT WAS CONFIRMED BY A COMPANY REPRESENTATIVE WHO ADJUSTED THE SETTINGS TO ADDRESS THE OFFSET VALUES. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. THE SYSTEM MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO THE FLAP SETTINGS OUT OF SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    SOFTWARE REVISION IS 2.3. A SERVICE VISIT WAS PERFORMED. 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).

    Description of Event or Problem · 1

    THE EVENT OCCURRED DURING FEMTOSECOND LASER FLAP TREATMENT.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED ABOUT A THICKENING OF THE FLAP DURING A CATARACT PROCEDURE. THE THICKENING WAS NOTICED AFTER THE SURGERY AS AN ADDITIONAL MEASUREMENT. THE THICKENING OF THE FLAP OCCURRED IN ONE DIRECTION. THERE WAS NO PATIENT HARM, AND POSTOPERATIVE PATIENT'S VISUAL ACUITY (VA) WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569917 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other