BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECHNOLAS EXCIMER WORKSTATION

    MDR report key: 1895503 · Received November 5, 2010

    Report

    Report Number
    3007606649-2010-00006
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    June 10, 2010
    Report Date
    August 5, 2010
    Manufacturer
    TECHNOLAS PERFECT VISION GMBH; JAUPTNIEDERLASSUNG/HQ
    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 PRELIMINARY ROOT CAUSE ANALYSIS INDICATED THAT EVENT APPEARED TO BE RELATED TO AN ELECTRONIC CIRCUIT BOARD HARDWARE ISSUE THAT WAS REPRODUCED BY (B)(4) IN THE LAB AFTER COMPONENT WAS RETURNED FOR ASSESSMENT. THE ELECTRONIC BOARD COMPONENT WAS SHIPPED TO THE OEM MFR FOR FURTHER EVAL. DESPITE EXHAUSTIVE TESTING, THE FAILURE COULD NOT BE REPRODUCED. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING BILATERAL LASIK SURGERY ON (B)(6) 2010 WITH THE TECHNOLAS EXCIMER WORKSTATION. AT THE PT'S 2ND POSTOPERATIVE VISIT (APPROX 2 MONTHS POSTOPERATIVELY) THE PT'S MANIFEST REFRACTION REVEALED THAT THE PT HAD SIGNIFICANT INDUCED ASTIGMATISM WITH OD>OS, ALTHOUGH THE BCVA WAS NOT SIGNIFICANTLY IMPACTED. THE PT'S PREOPERATIVE BCVA OD WAS 20/20 WITH MR OF -1.50 -0.05 X 005. POSTOPERATIVELY THE PT'S BCVA OD WAS 20/20-2 WITH MR PLANO + 3.00 X 109. THE PT'S PREOPERATIVE BCVA OS WAS 20/20 WITH MR OF -1.50 -0.75 X 180. POSTOPERATIVELY, THE PT'S BCVA OS WAS 20/25+2 WITH MR +1.00 + 1.75 X 107.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other