BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3761070 · Received April 10, 2014

    Report

    Report Number
    3003288808-2014-00638
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 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

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. LOGFILES REVIEW SHOWED THAT ALL TREATMENTS WERE COMPLETE TO 100% AND ALL USER SYSTEM FUNCTIONS WERE WITHIN SPECS ON THE DAY OF TREATMENT. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A PT WITH TRACE GRADE 1 CORNEAL HAZE IN BOTH EYES. THE PT'S TOPICAL STEROID DOSAGE WAS INCREASED. ADD'L INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS FILE IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216210 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention