BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 7082041 · Received December 5, 2017

    Report

    Report Number
    3008772169-2017-00561
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    November 13, 2017
    Report Date
    February 16, 2018
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS WITH ANY SURGICAL PROCEDURE, RISK IS INVOLVED. POSSIBLE COMPLICATIONS RESULTING FROM LAMELLAR FLAP RESECTION INCLUDE (BUT ARE NOT LIMITED TO): CORNEAL EDEMA, CORNEAL PAIN, EPITHELIAL IN-GROWTH, EPITHELIAL DEFECT, INFECTION, FLAP DECENTRATION, INCOMPLETE FLAP CREATION, FLAP TEARING OR INCOMPLETE LIFT-OFF AND FREE CAP. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (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 DOCTOR REPORTED AN INCOMPLETE CORNEAL FLAP CUT OF THE RIGHT EYE DURING CORNEAL FLAP CREATION. REPORTER INDICATED AN AIR BUBBLE APPEARED ON THE TEMPORAL SIDE WHERE THE SIDE CUT WAS TO BE TREATED. THE DOCTOR TOOK THE PATIENT UNDER THE LASER TO LIFT THE FLAP AND HAD TO USE SCISSORS TO COMPLETE THE SIDE CUT. THE AREA OF UNTREATED SIDE CUT WAS ABOUT 5 TO 6MM AND THE BED WAS SMOOTH AND EASY TO LIFT AFTER THE INTERVENTION TO THE SIDE CUT. REPORTER INDICATED THE FLAP WENT BACK DOWN PREFECT, AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861041 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other