BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 5061636 · Received September 8, 2015

    Report

    Report Number
    3008772169-2015-00694
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Date of Event
    July 25, 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
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED. HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED. BASED ON QUALITY ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. (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 MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED UNCUT AREA OF TREATMENT IN THE LEFT EYE. THE UNCUT AREA LEAD TO DIFFICULTIES IN LIFTING THE FLAP. THE FLAP WAS NOTED VERY THIN AND THE EDGES OF THE CUTS WERE NOT SMOOTH. THE TREATMENT WAS ABLE TO BE COMPLETED WITH NO HARM TO THE PATIENT. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S LEFT EYE, AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591412 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other