BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3675056 · Received February 21, 2014

    Report

    Report Number
    3003288808-2014-00273
    Event Type
    Injury
    Date Received
    February 21, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 23, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    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 21CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED TWO WEEKS FOLLOWING PHOTO REFRACTIVE KERATECTOMY (PRK), A PATIENT REPORTED OCULAR IRRITATION/DISCOMFORT AND DISTORTED VISION IN THE RIGHT EYE. THE PATIENT REPORTED LINES APPEARED BENT OR WAVY. A DILATED FUNDUS EXAM (DFE) REVEALED POSSIBLE MACULAR STRIAE IN THE RIGHT EYE. IN A F/U WITH THE OPTOMETRIST, HE INDICATED THE DISTORTED VISION AND POSSIBLE MACULAR STRIAE WERE NOT RELATED TO THE EXCIMER LASER. THE PATIENT WAS REFERRED TO A RETINAL SPECIALIST FOR EVALUATION. HE ALSO REPORTED THE OCULAR SURFACE LOOKED GOOD BUT THE PATIENT COULD HAVE MILD DRY EYE. THE PATIENT IS USING ARTIFICIAL TEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109184 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention