BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 2854179 · Received November 29, 2012

    Report

    Report Number
    3008772169-2012-00044
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 2, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE. THE SURGEON LATER COMMENTED THAT HE THOUGHT THE CAPSULAR TEARS WERE POTENTIALLY RELATED TO AN INCOMPLETE CAPSULOTOMY, HOWEVER HE WAS UNABLE TO SEE THE CAPSULE MARGIN TO DETERMINE IF THERE WERE TAGS PRIOR TO REMOVING THE CAPSULE. IT WAS ALSO REVEALED THAT INTRAOPERATIVELY, AN IRIS EXPANSION RING WAS USED BECAUSE THE PUPIL WAS NOT STAYING DILATED AND THE PT HAD A HISTORY OF POOR DILATATION. POOR VISIBILITY AND IOL REPOSITIONING ARE KNOWN RISK FACTORS FOR CAPSULAR TEARS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NOTICING TWO CAPSULAR TEARS AFTER IMPLANTING THE INTRAOCULAR LENS. THE PT WAS DILATED TO 8 MM DURING THE LASER PROCEDURE. THE PHACO PROCEDURE WAS STARTED 15 MINS FOLLOWING COMPLETION OF THE LASER PROCEDURE WAS STARTED 15 MINS FOLLOWING COMPLETION OF THE LASER PROCEDURE AND BY THIS TIME THE DILATION WAS APPROX 5 MM. THE CAPSULE SETTING WAS 5.3 MM, THUS THE MARGINS OF THE CAPSULE WERE NOT VISIBLE DURING THE CAPSULE REMOVAL, PHACO, AND CORTEX PORTIONS OF THE PROCEDURE. THE INTRAOCULAR LENS WAS INSERTED BACKWARDS AND THE SURGEON NOTICED THIS AFTER INJECTING INTO THE BAG. THE SURGEON REPOSITIONED THE IOL AND THIS IS WHEN THE CAPSULAR TEARS WERE NOTICED AT 120 DEGREES AND 250 DEGREES (BOTH OF WHICH PROGRESSED PAST THE MERIDIAN). AN ANTERIOR VITRECTOMY WAS PERFORMED AND A 3-PIECE INTRAOCULAR LENS WAS PLACED IN THE SULCUS FOLLOWING THE REMOVAL OF THE ORIGINAL IOL.

    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 62 YR Required Intervention (B)(4) INTRAOCULAR LENS