BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECHNOLAS EXCIMER WORKSTATION

    MDR report key: 1757025 · Received July 12, 2010

    Report

    Report Number
    3007606649-2010-00004
    Event Type
    Injury
    Date Received
    July 12, 2010
    Date of Event
    June 10, 2010
    Report Date
    June 12, 2010
    Manufacturer
    TECHNOLAS PERFECT VISION GMBH
    Product Code
    LZS
    PMA / PMN Number
    P990027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS IN PROGRESS AND THE FINDINGS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE PRELIMINARY ROOT CAUSE ANALYSIS INDICATES THAT EVENT APPEARS TO BE RELATED TO AN ELECTRONIC CIRCUIT BOARD HARDWARE ISSUE THAT WAS REPRODUCED BY TPV IN THE LAB AFTER COMPONENT WAS RETURNED FOR ASSESSMENT. THE ELECTRONIC BOARD COMPONENT HAS BEEN SHIPPED TO THE OEM MANUFACTURER FOR FURTHER EVALUATION. (B) (4).

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING BILATERAL LASIK SURGERY WITH THE (B) (6) EXCIMER WORKSTATION. ONE WEEK POSTOPERATIVELY, THE PATIENT PRESENTED WITH INDUCED ASTIGMATISM. THE PATIENT'S PREOPERATIVE BCVA OD WAS 20/20 WITH MR OF -2.25 SPHERE AND BCVA OS WAS 20/20 WITH MR OF -2.25 SPHERE. FOUR DAYS POSTOPERATIVELY, THE SURGEON PERFORMED LASIK RETREATMENT. AFTER RETREATMENT, THE MR OD CHANGED TO +0.25 +4.00 X 115 AND THE MR OS CHANGED TO +1/00 +3.50 X 115; BCVAS NOT AVAILABLE. ONE WEEK POSTOPERATIVELY, BCVA OD CHANGED TO 20/20 WITH MR OF -3.25 +3.00 X 010 AND BCVA OS CHANGED TO 20/20 WITH MR OF -2.75 +1.75 X 015. THE PATIENT HAS BEEN PRESCRIBED GLASSES WHILE WAITING FOR VISION TO STABILIZE. UPON STABILIZATION, THE SURGEON PLANS TO PERFORM LASIK RETREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECHNOLAS EXCIMER WORKSTATION EXCIMER LASER SYSTEM LZS TECHNOLAS PERFECT VISION GMBH 217AZ100 UPGRADE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other