BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4-IR-ETL EXCIMER LASER

    MDR report key: 3191363 · Received June 26, 2013

    Report

    Report Number
    3006695864-2013-00233
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): UNDERCORRECTED VISION. AN AMO FIELD SERVICE ENGINEER PERFORMED A COMPLETE COMPREHENSIVE CHECK OF THE SYSTEM AT THE CUSTOMER'S LOCATION. ALL FUNCTIONS WERE FOUND TO WITHIN SPECIFICATION AND NO ISSUES WERE FOUND WITH THE SYSTEM. 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 FOLLOWING LASER VISION SURGERY WITH AN UNDER-CORRECTED TREATMENT IN EACH EYE. AT THE TWO WEEK POST OP EXAM THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/20 IN THE RIGHT EYE AND 20/25 IN THE LEFT EYE. THE PATIENT'S PRE-OP BCVA WAS 20/15 IN EACH EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291243 STAR S4-IR-ETL EXCIMER LASER EXCIMER LASER LZS ABBOTT MEDICAL OPTICS S4-IR-ETL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other