BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S4-IR-ETL EXCIMER LASER

    MDR report key: 3183059 · Received June 21, 2013

    Report

    Report Number
    3006695864-2013-00227
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 1, 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). THE AMO FIELD SERVICE ENGINEER INSPECTED THE SYSTEM AT THE CUSTOMER'S LOCATION AND FOUND THE SYSTEM TO BE OPERATING PER IT'S SPECIFICATION. NO ISSUES WERE FOUND WITH THE SYSTEM. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION -THE PATIENT RECEIVED A RETREATMENT AND IS REPORTED TO BE DOING FINE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED STATED THAT THIS PATIENT DID NOT UNDERGO RETREATMENT AND IS FINE NOW. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED AT A POST OP EXAM WITH AN OVERCORRECTED VISION IN EACH EYE. THE PATIENT'S POST OP BEST CORRECTED VISUAL ACUITY WAS 6/9 (20/30) IN EACH EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282615 S4-IR-ETL EXCIMER LASER EXCIMER LASER LZS ABBOTT MEDICAL OPTICS S4-IR-ETL

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other