BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOT MEDICAL OPTICS VISX S4

    MDR report key: 2657349 · Received July 11, 2012

    Report

    Report Number
    MW5026158
    Event Type
    Injury
    Date Received
    July 11, 2012
    Date of Event
    September 9, 2011
    Report Date
    July 11, 2012
    Manufacturer
    ABBOTT LABORATORIES INC
    Product Code
    LZS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, I UNDERWENT A CUSTOMVUE LASIK ENHANCEMENT WITH AN AMO (ABBOTT MEDICAL OPTICS) VISX STAR S4 TO TREAT THE RESIDUAL HYPEROPIA AND ASTIGMATISM IN MY LEFT EYE FROM A PREVIOUS CUSTOMVUE LASIK. MY LEFT EYE HAS EXPERIENCED SIGNIFICANT DECREASED VISION AFTER THE PROCEDURE. IT HAS PREVENTED ME FROM READING AS WELL AS EVENING-DRIVING WITH MY LEFT EYE. MY CORNEAL SPECIALIST FEELS THIS IS DUE TO IRREGULAR ASTIGMATISM AS A RESULT OF THE ENHANCEMENT PROCEDURE. DURING THE PROCEDURE, THE ACTIVETRAK AND IRIS REGISTRATION FEATURE APPEARED TO NOT HAVE WORKED THE WAY THEY WERE INTENDED AND RESULTED IN A DE-CENTERED ABLATION PATTERN AND DETERIORATED VISION. I HAVE CONTACTED THE (B)(6), DR. (B)(6), AND SUBMITTED THE RELEVANT TESTS/LAB DATA/OPERATIVE REPORT FOR HIS REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOT MEDICAL OPTICS VISX S4 VISX STAR S4 WAVEFRONT CUSTOMVUE WITH ACTIVE TRAK & LZS ABBOTT LABORATORIES INC VISX STAR S4 SOFTWARE 5.22

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR