BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE

    MDR report key: 2139214 · Received June 16, 2011

    Report

    Report Number
    3003288808-2011-00139
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 1, 2008
    Report Date
    May 14, 2008
    Manufacturer
    ALCON - IRVINCE TECHNOLOGY CENTER
    Product Code
    LZS
    PMA / PMN Number
    P030008/P0
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE ON SITE INVESTIGATION, THE SERVICE TECH FOUND NO EVIDENCE OF SYSTEM ERROR. THE ROOT CAUSE COULD NOT BE DETERMINED, AS THE SYSTEM WAS FOUND TO BE OPERATING WITHIN SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS A PATIENT WITH AN OVERCORRECTION IN THE LEFT EYE FOLLOWING REFRACTIVE SURGERY. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRETTO WAVE OPHTHALMIC EXCIMER LASER SYSTEM LZS ALCON - IRVINCE TECHNOLOGY CENTER 8065990600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other