BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 3891761 · Received June 10, 2014

    Report

    Report Number
    3008772169-2014-00067
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    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
    CA, 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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A RADIAL TEAR WAS NOTICED SUB INCISIONAL DURING IRRIGATION AND ASPIRATION OF A LASER ASSISTED CATARACT SURGERY. A SULCUS LENS WAS PLACED TO SUCCESSFULLY COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339286 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX LASERS, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention