BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3954729 · Received July 18, 2014

    Report

    Report Number
    3003288808-2014-01138
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 THREE MONTHS FOLLOWING LAS SURGERY, A PT WAS DIAGNOSED WITH NON-SPECIFIC STROMAL INFLAMMATION IN THE LEFT EYE. PER THE OPTOMETRIST, THE INFLAMMATION WAS NOTED IN THE SUPERO-NASAL AREA OF THE CORNEA, WITHIN AND OUTSIDE THE FLAP ZONE. THE PT REPORTED THAT SHE GETS SECTORAL, SUPERIOR CONJUNCTIVAL INJECTION WHEN RIDING THE BIKE OR WALKING IN THE WIND. THE STEROID DROPS WERE INCREASED TO TREAT THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422141 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention INTRALASE