BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRATTO WAVE

    MDR report key: 2231184 · Received August 26, 2011

    Report

    Report Number
    3003288808-2011-00245
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 27, 2011
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008/P0
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE ONSITE INVESTIGATION, THE FIELD SERVICE ENGINEER COULD NOT FIND ANY ISSUES WITH THE SYSTEM. AS A PREVENTATIVE MEASURE FSE REPLACED TWO 45 DEGREES MIRRORS AND MAIN LENS, AND PERFORMED ALIGNMENT OF ALL OPTICAL PATHS OF THE LASER AND SUCCESSFULLY COMPLETED THE SYSTEM VERIFICATION. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    FACILITY REPRESENTATIVE REPORTS A PATIENT THAT EXPERIENCED 'HYPERCORRECTION', AFTER REFRACTIVE SURGERY. PATIENT PRESENTED AS A HYPEROPE ON PRE-OP, AND POST-OP MEASUREMENT PROVIDED SHOWS A MYOPIC REFRACTIVE ERROR. MORE PATIENT INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRATTO WAVE OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other