BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 2496416 · Received March 15, 2012

    Report

    Report Number
    3008772169-2012-00012
    Event Type
    Injury
    Date Received
    March 15, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 14, 2012
    Manufacturer
    ALCON - LENSX LASERS, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED, AND THERE WERE NO UNUSUAL FINDINGS RELATED TO THE REPORTED INCIDENT. NO DEVICE MALFUNCTION SUSPECTED TO WARRANT A DISPATCH OF SERVICE ENGINEER. THE DEVICE WAS EVALUATED WITH REGARD TO CLINICAL SETTING AND THE EVENT WAS BELIEVED TO BE ATTRIBUTED TO USER ERROR; INADEQUATE DILATION. THE DEVICE LABELING PROVIDES INSTRUCTIONS FOR ENSURING ADEQUATE DILATION DURING THE PROCEDURE. (B)(4).

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE OBSERVED AND REPORTED, ON BEHALF OF THE SURGEON, AN UNANTICIPATED 'NICKED' CAPSULAR EDGE THAT EXTENDED TO A TEAR, DURING THE PHACOEMULSIFICATION PART OF THE PROCEDURE. EVENT CONDITIONS INCLUDED POORLY DILATED PUPIL PRE-OPERATIVELY WHICH WAS VERY CLOSE TO THE PUPILARY EDGE DURING THE LASER PROCEDURE. THE CAPSULOTOMY WAS DEEMED COMPLETED. LENS PHACOEMULSIFICATION PROCESS WAS COMPLETED BUT CORTICAL IRRIGATION AND ASPIRATION WAS NOT OPTIMAL. SULCUS LENS WAS IMPLANTED. IN THE SURGEON'S OPINION, THE LIKELY ROOT CAUSE FOR THE TEAR MAY HAVE BEEN AN UNSEEN CAPSULAR TAG WHICH MAY HAVE EXTENDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention