BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 4121314 · Received September 22, 2014

    Report

    Report Number
    3003288808-2014-01424
    Event Type
    Injury
    Date Received
    September 22, 2014
    Date of Event
    July 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    GEX
    PMA / PMN Number
    K101006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) FOR THE DEVICE WERE REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON ACCEPTANCE CRITERIA. 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 SURGICAL COORDINATOR REPORTED THAT A PATIENT IS EXPERIENCING "RAINBOW GLARE" IN THE RIGHT EYE FOLLOWING BILATERAL LASIK SURGERY. A COMPLETED QUESTIONNAIRE WAS RECEIVED, WHICH INDICATED THAT THE PATIENT ALSO EXPERIENCED HALOS. A COMPLETED QUESTIONNAIRE WAS RECEIVED, WHICH INDICATED THAT THE PATIENT ALSO EXPERIENCED HALOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587521 WAVELIGHT FS200 FEMTOSECOND LASER OPHTHALMIC FEMTOSECOND LASER GEX WAVELIGHT GMBH FS200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other VISX STAR S4 EXCIMER LASER