BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO

    MDR report key: 3040109 · Received April 3, 2013

    Report

    Report Number
    3003288808-2013-00148
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 8, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE RECEIVED CORRESPONDENCE INDICATING UNDER CORRECTION OF "ONE DEGREE" ON BILATERAL LASIK PROCEDURE. THIS REPORT IS FOR THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136735 CONCERTO OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990602 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other