BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADARVISION 4000

    MDR report key: 1061312 · Received June 13, 2008

    Report

    Report Number
    1061857-2008-00106
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    March 13, 2008
    Report Date
    May 15, 2008
    Manufacturer
    ALCON - ORLANDO TECHNOLOGY CENTER
    Product Code
    LZS
    PMA / PMN Number
    P970043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SURGERY DATABASE PERFORMANCE VERIFICATION WAS CONDUCTED ON THIS SYSTEM AND THE ANALYSIS DETERMINED THE LASER PERFORMANCE FACTORS ANALYZED WERE OPERATING WITH SPECIFICATION DURING THE TIME OF THE PT'S SURGERY. THIS REPORT MAILED IN TO FDA ON: 06/13/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS A PT THAT IS OVERCORRECTED FOLLOWING PRK REFRACTIVE SURGERY ON BOTH EYES. THIS REPORT IS FOR THE RIGHT EYE, THE LEFT EYE IS BEING REPORTED UNDER MFR REPORT #1061857-2008-00107. PATIENT RECORDS WERE REC'D AND INDICATE THE RIGHT EYE WAS NOT OVERCORRECTED, HOWEVER, THERE WAS -1.25 DIOPTER OF RESIDUAL ASTIGMATISM. THE PT ALSO REPORTED A SHADOW UNDERNEATH EVERYTHING AND WHEN LOOKING AT STOPLIGHTS, SEES ANOTHER UNDERNEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM LZS ALCON - ORLANDO TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other