BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDESIGN AWS SYSTEM

    MDR report key: 3269386 · Received August 7, 2013

    Report

    Report Number
    3006695864-2013-00317
    Event Type
    Injury
    Date Received
    August 7, 2013
    Date of Event
    July 10, 2013
    Report Date
    July 11, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNDERCORRECTED VISION ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE IDESIGN SYSTEM WAS FUNCTIONALLY TESTED AT THE MANUFACTURER FOR THE REPORTED ISSUE. THE SYSTEM WAS FOUND TO BE OPERATING AS DESIGNED. THERE WERE NO ANOMALOUS OUTPUTS AND THE UNIT MEASURED NOMINALLY. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: P930016. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    MANUFACTURING DATE: 09/20/2012, PLACEHOLDER.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A CLINICAL STUDY PATIENT WHO UNDERWENT A LASER VISION CORRECTION TREATMENT PRESENTED AT THE 6 MONTH POST OP EXAM WITH AN UNDERCORRECTED VISION OF 3 DIOPTERS DEVIATION FROM THE PRESCRIBED TREATMENT. THE PATIENT DID NOT HAVE ANY LOSS OF BEST CORRECTED VISUAL ACUITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370361 IDESIGN AWS SYSTEM REFRACTIVE MEASUREMENT LZS ABBOTT MEDICAL OPTICS 0110-0001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other