BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 3799581 · Received April 23, 2014

    Report

    Report Number
    3008772169-2014-00038
    Event Type
    Injury
    Date Received
    April 23, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 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 Occupation
    UNKNOWN

    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. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL HAS REPORTED FEMTOSECOND TREATMENT MAY HAVE CUT INTO THE ENDOTHELIUM. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245377 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX LASERS, INC 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other