BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3576678 · Received January 7, 2014

    Report

    Report Number
    3003288808-2014-00025
    Event Type
    Injury
    Date Received
    January 7, 2014
    Date of Event
    September 1, 2009
    Report Date
    December 10, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008/P0
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 INFO BECOMES AVAILABLE. MARCUS ANG. FRCS(ED), JODHBIR S. MEHTA, FRCOPH, MOHAMAD ROSMAN, FRCS(ED), LIM LI, FRCS(ED), JANE C. W. KOH, ADV. DIP. STATISTICS, HLA M. HTOON, PHD, DONALD TAN, FRCOPH, CORDELIA CHAN, FRCS(ED). VISUAL OUTCOMES COMPARISON OF 2 FEMTOSECOND LASER PLATFORMS FOR LASER IN SITU KERATOMILEUSIS. J CATARACT REFRACT SURG 2013; 39:1647-1652. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE ARTICLE: VISUAL OUTCOMES COMPARISON OF 2 FEMTOSECOND LASER PLATFORMS FOR LASER IN SITU KERATOMILEUSIS, FIRST AUTHOR NOTES A CASE OF DIFFUSE LAMELLAR KERATITIS, IN THE 500 KHZ FEMTOSECOND LASER GROUP, THAT OCCURRED IN 1 EYE AND WAS SUCCESSFULLY TREATED WITH TOPICAL CORTICOSTEROIDS, THERE ARE TWO REPORTS, ASSOCIATED WITH THIS LITERATURE ARTICLE, AND THIS REPORT WILL REFERENCE THE FIRST ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10345 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990631 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VISUMAX