BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S4

    MDR report key: 3781074 · Received April 30, 2014

    Report

    Report Number
    3006695864-2014-00255
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 20, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE SPECIALIST VISITED THE ACCOUNT AND CHECKED THE SYSTEM AND THERE WAS NO TECHNICAL TROUBLE FOUND. MINOR ADJUSTMENT WAS DONE AS IT WAS FOUND SLIGHTLY POSITIVE BUT WITHIN RANGE. SURGEON WAS IN DOUBT DURING THIS SESSION BECAUSE HE SAID HE WAS NOT ABLE TO SEE THE BEAM SHOTS ON SCREEN AS HE IS USED TO WATCH, GIVING HIM THE IMPRESSION THE BEAM WAS NOT POWERFUL ENOUGH. FIELD SERVICE SPECIALIST EXPLAINED THAT IF A POWER LOSS OCCURS THE SYSTEM WOULD STOP AND REPORT AN ERROR CONDITION, WHICH WAS NOT THE CASE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT PATIENT PRESENTED WITH UNDERCORRECTION POST TREATMENT OF -0.25. SURGEON SAID THAT LASER WAS NOT POWERFUL ENOUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259782 S4 EXCIMER LASER LZS ABBOTT MEDICAL OPTICS 0030-4638

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention