BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3934301 · Received June 27, 2014

    Report

    Report Number
    3003288808-2014-01045
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 30, 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
    NURSE

    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

    A NURSE REPORTED THAT TWO WEEKS FOLLOWING PHOTO REFRACTIVE KERATECTOMY (PRK), THE PT PRESENTED WITH BLURRED VISION AND PHOTOPHOBIA. THE TOPICAL STEROID DROPS WERE INCREASED. IN A COMPLETED QUESTIONNAIRE, THE OPTOMETRIST REPORTED THAT THE EVENT RESOLVED AFTER TWO WEEKS OF TREATMENT. PER THE OPTOMETRIST, THE SURGEON DOES NOT BLAME THE LASER FOR THE EVENT. THERE ARE TWO MED DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377403 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYS LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention