BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDESIGN AWS SYSTEM

    MDR report key: 3191320 · Received June 26, 2013

    Report

    Report Number
    3006695864-2013-00230
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    March 22, 2013
    Report Date
    June 8, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HKO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): UNDERCORRECTED VISION. DEVICE CURRENTLY NOT MARKETED IN THE US. AN AMO AUTHORIZED REPRESENTATIVE EVALUATED THE SYSTEM AT THE CUSTOMER LOCATION AND FOUND THAT THE CUSTOMER HAD CHANGED THE LANE LENGTH OF THE MANIFEST REFRACTION DEVICE (MR) BUT DID NOT UPDATE THE LANE LENGTH IN THE IDESIGN TO CORRESPOND WITH THE CHANGE. FIELD SERVICE CORRECTED THE SETTINGS IN THE IDESIGN TO MATCH THE MR. INSTRUCTIONS WERE PROVIDED TO THE CUSTOMERS BY THE AMO CLINICAL DEVELOPMENT MANAGER STRESSING THE IMPORTANCE OF FOLLOWING THE PROTOCOL FOR MATCHING THE MR WITH IDESIGN SCAN AND TO USE THE RECOMMENDED NOMOGRAM. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FOR THE PATIENT, AUTO REFRACTION MEASUREMENT TAKEN ON (B)(6) 2013 RESULTS: OD: +0.25S +0.50D X 130, OS: +0.25S, BCVA ¿ 6/6P (20/20) FOR BOTH OD AND OS. AFTER THIS DATE PATIENT HAS NOT COME BACK TO CLINIC FOR CHECK UP. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS RETREATED FOR UNDERCORRECTIONS AND THEIR UNCORRECTED VISUAL ACUITY IS NOW 6/9 (APPROXIMATELY 20/30). POST OP BEST CORRECTED VISUAL ACUITY IS NOT AVAILABLE. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED AT A POST OP EXAM WITH AN OVER CORRECTED VISION TREATMENT IN EACH EYE. THE PATIENT'S BEST CORRECTED VISUAL ACUITY WAS 6/18 (20/50).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290848 IDESIGN AWS SYSTEM REFRACTIVE MEASUREMENT HKO ABBOTT MEDICAL OPTICS 0110-0001

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other