BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4135900 · Received September 29, 2014

    Report

    Report Number
    3003288808-2014-01411
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON ACCEPTANCE CRITERIA. 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 PT WITH AN INFLAMED PTERYGIUM (OS), DRY EYE, RED EYE, PAIN UPON EYE MOVEMENT, SHARP PAIN IN THE EYE IN THE MORNING, AND INTERMITTENT CLOUDY VISION 2 MONTHS AFTER A LASIK PROCEDURE. THE SYMPTOMS ARE BEING TREATED BY INCREASING THE PRESCRIBED STEROID DROPS. ADDITIONAL INFO RECEIVED STATES THAT THE PT IS DOING BETTER AND WAS NOT CONSISTENT WITH THE STEROID DROP REGIMEN SO TREATMENT HAS BEEN DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606241 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention INTRALASE