BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3890848 · Received June 11, 2014

    Report

    Report Number
    3003288808-2014-00965
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE. NO NEW INFORMATION HAS BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED THAT APPROXIMATELY THREE MONTHS FOLLOWING BILATERAL PHOTO REFRACTIVE KERATECTOMY (PRK), THE PATIENT PRESENTED WITH TRACE CORNEAL HAZE IN BOTH EYES. THE PATIENT REPORTED A MILD BLUR IN HIS VISION. THE TOPICAL STEROID DROPS WERE INCREASED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345970 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention