BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 4177633 · Received June 4, 2014

    Report

    Report Number
    3008772169-2014-00066
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ALCON - LENSX LASERS, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    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. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED FEMTOSECOND LASER FAILED TO MAKE INCISIONS AND ONLY CREATE AN IMPRINT OF THE CAPSULOTOMY ON THE RIGHT EYE. REPORTER INDICATED CAPSULOTOMY WAS PERFORMED MANUALLY BUT HAD TROUBLE SEEING DUE TO GAS BUBBLES. THE REPORTER INDICATED AN ANTERIOR CAPSULE TEAR OCCURRED WITH NO VITREOUS LOSS AND THE INTENDED INTRAOCULAR LENS (IOL) WAS IMPLANTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326931 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX LASERS, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other