BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4151954 · Received October 6, 2014

    Report

    Report Number
    3003288808-2014-01488
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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 SIX MONTHS FOLLOWING LASIK SURGERY, THE PATIENT CONTINUES TO REPORT FLUCTUATION OF VISION DUE TO DRYNESS IN THE LEFT EYE. THE PATIENT REPORTED THAT VISION IS BETTER IN THE MORNING, AND WORSENS AS THE DAY PROGRESSES. THE PATIENT ALSO REPORTED THAT SHE CANNOT READ DUE TO THE BLURRY VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624363 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other INTRALASE