BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4112591 · Received September 10, 2014

    Report

    Report Number
    3003288808-2014-01362
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    May 30, 2014
    Report Date
    August 15, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED THAT A PATIENT PRESENTED WITH INFILTRATIVE KERATITIS IN THE RIGHT EYE, TWO AND A HALF MONTHS FOLLOWING LASIK SURGERY. TOPICAL STEROID DOSAGE WAS INCREASED TO TREAT THE EVENT. THE PATIENT STATED "IT FEELS LIKE SOMETHING MIGHT BE IN THE RIGHT EYE". ADDITIONAL INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559503 ALLEGRETTO WAVE EYE-Q OPTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention INTRALASE