BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYS

    MDR report key: 3934326 · Received June 27, 2014

    Report

    Report Number
    3008772169-2014-00070
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A CAPSULAR ADHESION RESULTING IN CAPSULAR TEAR EXTENDING TO THE POSTERIOR POLE. ADDITIONAL INFO FROM REPORTED INDICATED NO VITRECTOMY WAS REQUIRED AND THE INTENDED INTRAOCULAR LENS (IOL) WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378201 LENSX LASER SYS OPHTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX LASERS, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other