BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4213029 · Received October 24, 2014

    Report

    Report Number
    3003288808-2014-01577
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO, AT THIS TIME ADDITIONAL INFO HAS NOT BEEN RECEIVED. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A BILATERAL CASE OF TRACE DIFFUSE LAMELLAR KERATITIS (DLK), OBSERVED AT ONE DAY POST LASIK TREATMENT. REPORTER INDICATED TOPICAL STEROID EYE DROPS WERE INCREASED. PT NOTED BLURRY VISION, DISCOMFORT, TEARING AND EXTREME SENSITIVITY LIGHT. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO AT THIS TIME ADDITIONAL INFO HAS NOT BEEN RECEIVED. THERE ARE TWO RELATED REPORTS FOR THIS PT. THIS REPORT ADDRESSES THE PT'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
    678917 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention INTRALASE