BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4173976 · Received October 1, 2014

    Report

    Report Number
    3003288808-2014-01414
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 15, 2014
    Report Date
    September 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
    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

    AN OPTOMETRIST REPORTED A PATIENT EXPERIENCED FUZZY VISION APPROXIMATELY 1 MONTH POST LASIK SURGERY AND WAS REPORTED TO HAVE VERY FAINT MICROSTRIAE NEAR THE TEMPORAL PUPIL MARGIN IN THE LEFT EYE. NO ADDITIONAL TREATMENT NEEDED. THE PATIENT HAS A FOLLOW UP APPOINTMENT SCHEDULED FOR THE NEAR FUTURE. ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT WAS SEEN IN FOLLOW UP AND NOTED TO HAVE CLEAR CORNEAS AND IS NO LONGER COMPLAINING OF BLURRY VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611481 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other INTRALASE