BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4121067 · Received September 24, 2014

    Report

    Report Number
    3003288808-2014-01450
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    June 27, 2014
    Report Date
    August 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
    MN, 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

    AN OPTOMETRIST REPORTED A PT WITH DRY EYE AT THREE MONTH PHOTOREFRACTIVE KERATECTOMY (PRK) POST-OPERATIVE VISIT. AT VISIT PT COMPLAINED OF "EYELIDS STICKING TO CORNEA AND VISION FLUCTUATION". ADDITIONAL INFORMATION FROM REPORTER INDICATED REPORTED ISSUE CONTINUES AND HAS NOT YET RESOLVED. REPORTER INDICATED THE REPORTED ISSUE IS BEING TREATED WITH WARM COMPRESSES, OMEGA THREE VITAMINS, LUBRICATING DROPS, AND PUNCTAL PLUGS. THIS REPORT IS FOR THE LEFT EYE, AND ADDITIONAL REPORT WILL BE FILED FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594650 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention