BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 1972389 · Received January 20, 2011

    Report

    Report Number
    3003288808-2011-00008
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 21, 2010
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    OPTOMETRIST REPORTS A PATIENT OUTCOME OF OVERCORRECTION AND INDUCED ASTIGMATISM, FOLLOWING LASIK SURGERY. THIS MDR WILL ADDRESS THE PATIENT'S LEFT EYE. RIGHT EYE, OF THE SAME PATIENT, WILL BE REPORTED UNDER MANUFACTURER REPORT # 3003288808-2011-00007. PATIENT RECORDS WERE RECEIVED, SHOWING PREOPERATIVE DATA POST OPERATIVE VISITS A 1 DAY, 8 DAYS AND 14 DAYS. RECORDS SHOW FINDING OF EDEMA ON ALL 3 POST OP VISITS, AND A 1 LINE LOSS OF BCVA AT DAY 14 POST OP. AN INVESTIGATION INTO THE POSSIBLE CAUSES, PRODUCT AND NON PRODUCT FACTORS, IS BEING CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other