BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4-IR-CE EXCIMER LASER

    MDR report key: 3191537 · Received June 26, 2013

    Report

    Report Number
    3006695864-2013-00238
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): UNDERCORRECTED VISION. THE AMO FIELD SERVICE ENGINEER EVALUATED THE SYSTEM AT THE CUSTOMER'S LOCATION. SPLASHES OF BALANCE SALT SOLUTION WERE FOUND ON THE OPTIC CLOSEST TO TREATING AREA AND ON THE TRACKER CAMERAS. THE DOCTOR WAS ADVISED OF THE FINDINGS AND INSTRUCTED TO AVOID SPLASHING UP INTO THE SYSTEM. INSTRUCTIONS WERE ALSO PROVIDED IN MAINTAINING THE RECOMMENDED TEMPERATURE AND HUMIDITY. THE OPTIC WAS REPLACED AND THE TRACKER CAMERAS WERE CLEANED TO ENSURE PROPER OPERATION. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED AT A POST OP EXAM WITH AN UNDERCORRECTION IN THE RIGHT EYE. THE CLINIC INDICATED THAT THE TRACKER WAS NOT WORKING AND PERFORMED THE TREATMENT WITH MANUAL TRACKING. THE LEFT EYE WAS NOT TREATED. IT IS NOT KNOWN IF THERE WAS ANY LOSS OF BEST CORRECTED VISUAL ACUITY. THE PATIENT'S PRE-OP REFRACTION WAS -10.50/-0.25/35 AND THE POST OP REFRACTION WAS -4.31/-0.67/100 ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291319 STAR S4-IR-CE EXCIMER LASER EXCIMER LASER LZS ABBOTT MEDICAL OPTICS S4-IR-CE

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other