BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4100753 · Received September 12, 2014

    Report

    Report Number
    3003288808-2014-01386
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    June 12, 2014
    Report Date
    August 15, 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 WAS REVIEWED AND THERE WERE NO UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE AND THE PRODUCT WAS RELEASED ACCORDING TO COMPANY ACCEPTABLE 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 WITH CORNEAL HAZE AT TWO MONTH PHOTOREFRACTIVE KERATECTOMY (PRK) POST-OPERATIVE VISIT. ADDITIONAL INFO FROM REPORTER INDICATED THAT THE PT'S TOPICAL STEROID DOSAGE WAS INCREASED WHICH HELPED TO RESOLVE THE REPORTED ISSUE AFTER SIX WEEKS. THIS REPORT IS FOR THE RIGHT EYE, AND ADDITIONAL REPORT WILL BE FILED FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565072 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention