BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 3951854 · Received July 2, 2014

    Report

    Report Number
    3003288808-2014-01049
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 6, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON ACCEPTANCE CRITERIA. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT IS EXPERIENCING RAINBOW VISION AND NIGHT GLARE FOLLOWING LASIK SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385694 WAVELIGHT FS200 FEMTOSECOND LASER OPHTHALMIC FEMTOSECOND LASER LZS WAVELIGHT GMBH FS200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other EX 500 LASER