BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3834601 · Received May 2, 2014

    Report

    Report Number
    3003288808-2014-00771
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 3, 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 INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A CASE OF DIFFUSE "3+" PUNCTATE EPITHELIAL KERATITIS (PEK), OBSERVED ON A PATIENT'S RIGHT EYE AT NINE MONTHS POST LASIK TREATMENT. REPORTER INDICATED THE PATIENT WAS USING LOTS OF NON-PRESERVATIVE FREE ARTIFICIAL TEARS. REPORTER RELAYED THE PATIENT WAS PLACED ON PRESERVATIVE FREE ARTIFICIAL TEARS AND CYCLOSPORINE OPHTHALMIC EMULSION. PATIENT NOTED BLUR AND DRYNESS IN THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265094 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention INTRALASE, ON