BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3940371 · Received June 26, 2014

    Report

    Report Number
    3003288808-2014-01027
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    May 31, 2014
    Report Date
    May 31, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE 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 PATIENT WITH MILD STAPH MARGINAL KERATITIS 1 DAY POST LASIK SURGERY. TOPICAL STEROID DOSAGE WAS INCREASED TO TREAT THE EVENT. THE PATIENT REPORTED MILDLY SCRATCHY SYMPTOMS. IN A FOLLOW UP THE CENTER DIRECTOR REPORTED THE EVENT IS IMPROVING. TH PATIENT IS BENIGN TREATED WITH TOPICAL PREDNISOLONE ACETATE, ARTIFICIAL TEARS AND ORAL DOXYCYCLINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373038 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