BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4241127 · Received November 5, 2014

    Report

    Report Number
    3003288808-2014-01587
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 10, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    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 REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED THAT A PATIENT PRESENTED WITH DRY EYES AND NOTED THAT THEIR VISION WAS GREAT APPROXIMATELY 1 MONTH POST LASIK. DURING THE SLIT LAMP EXAM, THE PATIENT WAS NOTED TO HAVE CORNEAL ABRASION, DRY EYES, AND A SMALL CLEAR FOREIGN BODY THAT WAS EMBEDDED IN THE RIGHT CORNEA PERI-CENTRALLY. THE FOREIGN BODY WAS REMOVED USING A COTTON SWAB AND PROPARACAINE. THE PATIENT WAS PRESCRIBED TOPICAL EYE DROPS AND WILL FOLLOW UP AT A LATER DATE. ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THE PATIENT'S CORNEA IS CLEAR AND ALL DROPS HAVE BEEN DISCONTINUED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711739 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention INTRALASE