BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 1972382 · Received January 20, 2011

    Report

    Report Number
    3003288808-2011-00010
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    December 11, 2010
    Report Date
    December 21, 2010
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. (B)(4).

    Description of Event or Problem · 1

    OPTOMETRIST REPORTS A PATIENT OUTCOME OF OVERCORRECTION AND INDUCED ASTIGMATISM, FOLLOWING LASIK SURGERY. THE MDR WILL ADDRESS THE PATIENT'S LEFT EYE. RIGHT EYE OF THE SAME PATIENT WILL BE REPORTED UNDER MANUFACTURER REPORT # 3003288808-2011-00009. PATIENT RECORDS WERE RECEIVED, SHOWING PREOPERATIVE DATA AND POST OPERATIVE VISITS AT 1 DAY AND 4 DAYS. RECORDS NOTE TRACE EDEMA OS, AND DECREASE OF UCVA FROM 20/150 PRE OP TO 20/200 POST OP, ON DAY 4 POST OP VISIT. AN INVESTIGATION INTO THE POSSIBLE CAUSES, PRODUCT AND NON PRODUCT FACTORS, IS BEING CONDUCTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other SYNTHROID