BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 1772311 · Received July 23, 2010

    Report

    Report Number
    3003288808-2010-00394
    Event Type
    Injury
    Date Received
    July 23, 2010
    Report Date
    June 23, 2010
    Manufacturer
    WAVELIGHT AG (PRESSATH)
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "HIGHER ORDER ABERRATIONS FOLLOWING LASIK" (VISION, IMPAIRED). PRODUCT PROBLEM(S): "INDUCES HIGHER ORDER ABERRATIONS" (NO CODE AVAILABLE). INFO WAS RECEIVED FROM A JOURNAL ARTICLE INDICATING WAVEFRONT-OPTIMIZED MYOPIC LASIK IMPROVES VISION, BUT INDUCES HIGHER ORDER ABERRATIONS (HOA). F/U WITH THE SURGEON/AUTHOR INDICATES NO CONCERN FOR PT HARM OR INJURY WITH REFERENCE TO THE PTS NOTED IN THE JOURNAL ARTICLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other