BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4151917 · Received October 6, 2014

    Report

    Report Number
    3003288808-2014-01418
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 5, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. 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

    A CLINICAL MANAGER REPORTED A PATIENT HAVING FOREIGN BODY SENSATION IN THE LEFT EYE 1 DAY POST LASIK SURGERY. HE WAS NOTED TO HAVE MILD DIFFUSE LAMELLAR KERATITIS (DLK). THE TOPICAL STEROID DROPS WERE INCREASED. ADDITIONAL INFORMATION STATES THAT THE PATIENT HAS STERILE INFILTRATES IN BOTH EYES. THE PATIENT WAS NOTED TO HAVE NO VISUAL COMPLAINTS, DISCOMFORT, OR DRYNESS, THEREFORE, THE PATIENT IS NO LONGER ON TREATMENT AND WILL BE SEEN IN FOLLOW UP AS NEEDED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE PATIENT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623352 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention INTRALASE