BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 2483417 · Received March 6, 2012

    Report

    Report Number
    3008772169-2012-00011
    Event Type
    Injury
    Date Received
    March 6, 2012
    Date of Event
    February 13, 2013
    Report Date
    February 13, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS RELATED TO THE REPORTED INCIDENT. NO DEVICE MALFUNCTION SUSPECTED TO WARRANT DISPATCH OF SERVICE ENGINEER. THE DEVICE WAS EVALUATED WITH REGARD TO THE CLINICAL SETTING AND THE EVENT WAS BELIEVED TO BE ATTRIBUTED TO SURGICAL TECHNIQUE. ALTHOUGH THERE WAS A SMALL AREA (ONE CLOCK HOUR) OF INEFFECTIVE PHOTODISRUPTION IN THE CAPSULOTOMY PATTERN, IT CANNOT BE CONCLUDED THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE CAPSULAR TEAR SINCE THE INCISION IS UNDER THE PURVIEW OF THE SURGEON'S CAPSULORHEXIS SURGICAL MANEUVERS. CAPSULAR TEARS ARE AN INHERENT RISK OF CATARACT SURGERY. (B)(4).

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE WAS OBSERVING SURGERY AND REPORTED THAT THE LASER PROCEDURE WAS PERFORMED WITH NO ISSUES, HOWEVER, UPON REMOVAL OF THE CAPSULORHEXIS, IT WAS NOTED THAT THE LASER TREATMENT WAS INCOMPLETE AT THE 7-8 O'CLOCK POSITION. THE SURGEON WAS GIVEN DIFFERENT FORCEPS THAN USUAL, BUT PROCEEDED TO PERFORM THE CAPSULORHEXIS. AT THE 7 O'CLOCK JUNCTION, THE SURGEON PULLED TO THE MIDDLE OF THE PUPIL INSTEAD OF CONTINUING IN A CIRCULAR FASHION. AN ANTERIOR CAPSULAR TEAR WAS NOTED FROM THIS. THE TEAR WAS VERY SMALL, THE SURGEON TRIED TO REPAIR THE TEAR, BUT PROCEEDED TO MAKE THIS WORSE BEFORE THE CATARACTOUS LENS WAS REMOVED. AFTER THE LENS WAS REMOVED, THE SURGEON NOTED THAT THE TEAR WENT AROUND TO THE ZONULES AND WAS UNSURE IF IT EXTENDED TO THE POSTERIOR CAPSULE SO A SULCUS LENS WAS IMPLANTED AS A PRECAUTION. ACCORDING TO THE SURGEON, THE ROOT CAUSE WAS AN INCOMPLETE FLAP AND MISGUIDED CAPSULORHEXIS TO MAKE SURE OF COMPLETION; THE SURGEON COMMENTED THAT THEY FELT THEY MADE IT WORSE BY THE WAY THEY APPROACHED THE CAPSULORHEXIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX LASERS, INC. 50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention