BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK

    MDR report key: 1039141 · Received May 6, 2008

    Report

    Report Number
    MW5006751
    Event Type
    Injury
    Date Received
    May 6, 2008
    Date of Event
    April 14, 2000
    Report Date
    May 6, 2008
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT: BILATERAL LASIK REFRACTIVE SURGERY TO CORRECT NEARSIGHTEDNESS. OUTCOME: INITIALLY CORRECTED TO 20/25; ABOUT 3 MONTHS AFTER SURGERY, REGRESSION BEGAN, CAUSING NEARSIGHTEDNESS TO RETURN AND REQUIRING USE OF EXPENSIVE CUSTOM CONTACT LENSES TO ACHIEVE 20/20 VISION. NIGHT VISION SEVERLY DAMAGED: CORNEAL SURFACES HEALED WITH A NON-SMOOTH SURFACE, CAUSING SEVERE HIGHER ORDER ABERRATIONS -HOAS-, WHICH CAUSE VISUAL DISTURBANCES, INCLUDING: LARGE STARBURSTS WHEN LOOKING TOWARD ANY LIGHT SOURCE, SUCH AS CAR HEADLIGHTS. MULTIPLE -MORE THAN 20- IMAGES OF BRIGHT OBJECTS. MUCH POORER ABILITY TO DISCRIMINATE OBJECTS IN DARK OR DIM ROOMS. NIGHT VISION DISTURBANCES AND HOAS CANNOT BE CORRECTED WITH GLASSES, OR WITH MOST TYPES OF CONTACT LENSES. REQUIRE EXPENSIVE CUSTOM-MADE LARGE DIAMETER RIGID GAS PERMEABLE -RGP- CONTACT LENSES. ANNUAL EXPENSE FOR RGP LENSES AND SPECIAL CLEANING SOLUTIONS: FOR FIRST PAIR OF LENSES -INCLUDING PROFESSIONAL FEES- WITH DUPLICATE LENSES FOR EACH LENS. ANNUAL COST OF CLEANING SOLUTIONS AND DEVICES; DRY EYE CAUSED BY LASIK CAUSES DISCOMFORT WHEN USING CORRECTIVE CONTACT LENSES. BILATERAL LASIK REFRACTIVE SURGERY, 2000. DEVICE NAME UNKNOWN. DIAGNOSIS OR REASON FOR USE: NEARSIGHTED APPROX 11 CORRECTIVE LENSES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASIK LZS

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention