BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q EXCIMER LASER

    MDR report key: 4860172 · Received June 22, 2015

    Report

    Report Number
    3003288808-2015-05724
    Event Type
    Injury
    Date Received
    June 22, 2015
    Date of Event
    June 3, 2015
    Report Date
    August 26, 2015
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P020050
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    UPON ADDITIONAL FOLLOW UP, PATIENT IS REPORTED TO BE DOING WELL. NO PROBLEMS WERE NOTED.

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED DRY EYES AND LIGHT SENSITIVITY IN A PATIENT'S RIGHT EYE 2 MONTHS 21 DAYS AFTER LASIK. UPON FOLLOW UP, PATIENT WAS PRESCRIBED ARTIFICIAL TEARS AND CYCLOSPORINE OPHTHALMIC EMULSION TO USE. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S RIGHT EYE, AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404219 ALLEGRETTO WAVE EYE-Q EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention