BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3841024 · Received May 14, 2014

    Report

    Report Number
    3003288808-2014-00837
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND. THE ASSOCIATED DEVICE WA RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN MADE. NO NEW INFO HAS BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED THAT A PT WHO UNDERWENT BILATERAL LASIK WAS DIAGNOSED WITH TRACE DIFFUSE LAMELLAR KERATITIS (DLK) IN THE RIGHT EYE, AT THE ONE DAY POSTOPERATIVE VISIT. THE PT REPORTED SLIGHT FOREIGN BODY SENSATION, AND HAD NO VISUAL COMPLAINTS. THE TOPICAL STEROID DROPS WERE INCREASED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288029 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention INTRALASE