BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADARVISION 4000

    MDR report key: 819773 · Received February 16, 2007

    Report

    Report Number
    1061857-2007-00006
    Event Type
    Injury
    Date Received
    February 16, 2007
    Date of Event
    November 30, 2006
    Report Date
    January 9, 2007
    Manufacturer
    ALCON-ORLANDO TECHNOLOGY CTR
    Product Code
    DZS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SURGERY DATABASE DEVICE REPORT WAS CONDUCTED FOR THIS SYSTEM AND THE ANALYSIS DETERMINED THAT THE LASER PERFORMANCE FACTORS ANALYZED WERE OPERATING WITHIN SPECIFICATION DURING THE TIME OF THIS PT'S SURGERY.

    Description of Event or Problem · 1

    A SYSTEM OPERATOR REPORTS ONE CUSTOM HYPEROPIC PT WHO IS OVER CORRECTED FOLLOWING LASIK SURGERY. PT RECORDS WERE PROVIDED AND INDICATE THIS PT WAS TREATED FOR A MONOVISION OUTCOME, THE RIGHT EYE TREATED FOR DISTANCE. AT APPROX 2 MONTHS POST-OP, THIS PT EXHIBITED A DECREASE OF 3 LINES BCVA IN THE RIGHT EYE. ADD'L INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other