BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALEGRETTO WAVE EYE-Q

    MDR report key: 3900062 · Received May 27, 2014

    Report

    Report Number
    3003288808-2014-00908
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A CASE OF STAGE 2 DIFFUSE LAMELLAR KERATITIS OBSERVED IN A PATIENT'S LEFT EYE AT THREE DAYS POST LASIK TREATMENT. REPORTER INDICATED TOPICAL STEROID EYE DROP DOSAGE WAS INCREASED. PATIENT NOTED SLIGHT IRRITATION IN LEFT EYE, BUT "VISION WAS OK AND EYE WAS FEELING BETTER." ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311906 ALEGRETTO WAVE EYE-Q OPTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention INTRALASE