BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADARVISION 4000 LASER

    MDR report key: 1833790 · Received September 9, 2010

    Report

    Report Number
    1061857-2010-00013
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ALCON - ORLANDO TECHNOLOGY CENTER
    Product Code
    LZS
    PMA / PMN Number
    P970043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO CONCERNS FOR HARM OR INJURY" (NO CONSEQUENCES OR IMPACT TO PATIENT); "MILD UNDERCORRECTION" (BLURRED VISION). PRODUCT PROBLEM(S): "TRACKER JITTER" (FAILURE TO ALIGN [LASER]). A LASER TECHNICIAN REPORTS TRACKER JITTER DURING THE LAST 20% OF THE PROCEDURE ON A PATIENT'S RIGHT EYE. THE TREATMENT WAS FINISHED AND THERE WERE NO TRACKER ISSUES ON THIS PATIENT'S LEFT EYE NOR ON THE NEXT PATIENT. POST-OP DAY 2, THE PATIENT WAS 20/30 UCVA IN THE RIGHT EYE. THE TECHNICIAN STATED THE CURRENT OUTCOME WAS AS EXPECTED AS THE PATIENT WAS A HIGH MYOPE, THE PATIENT WAS DOING WELL AND THE SURGEON DID NOT HAVE ANY CONCERNS FOR HARM OR INJURY. FOLLOW-UP INFO INDICATES AT DAY 11 POST-OP, THE PATIENT'S UCVA IN THE RIGHT EYE WAS 20/50 AND THE CHART NOTED A MILD UNDERCORRECTION. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other