BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3925406 · Received June 18, 2014

    Report

    Report Number
    3003288808-2014-00993
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    January 8, 2014
    Report Date
    May 20, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A PT WAS DIAGNOSED WITH CORNEAL HAZE BILATERALLY APPROXIMATELY 7 WEEKS POST PHOTO REFRACTIVE KERATECTOMY SURGERY. TOPICAL STEROID DOSAGE WAS INCREASED TO RESOLVE THE EVENT, AND THE PT WAS ASYMPTOMATIC. IN A FOLLOW UP, A TECHNICIAN REPORTED THE EVENT HAD RESOLVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356740 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention