BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK

    MDR report key: 1212031 · Received October 24, 2008

    Report

    Report Number
    MW5008771
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    April 20, 2007
    Report Date
    October 24, 2008
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD LASIK EYE SURGERY ON BOTH EYES. I WAS AT -3 DIOPTER WITH SLIGHT ASTIGMATISM IN BOTH EYES BEFORE THE SURGERY. I WAS NEAR SIGHTED. BEFORE THE SURGERY AND DURING THE SURGERY, I WAS NOT GIVEN ANY INSTRUCTION ON WHAT TO DO WITH MY EYES. THE NIGHT BEFORE I READ IN THE PREP BOOKLET THAT I WAS SUPPOSED TO FOCUS ON THE LIGHT. FOLLOWING THIS DIRECTION I FOCUSED ON THE LIGHT DURING THE SURGERY FOR MY RIGHT EYE, BUT WHEN IT CAME TO MY LEFT EYE, I HAD TROUBLE FOCUSING ON THE LIGHT, SO I MOVED MY EYE TO RE-FOCUS, AND AFTER THE SECOND TIME OF DOING THIS, THE DOCTOR FINALLY DIRECTED ME TO STOP MOVING MY EYE. ANYWAY, AFTER THE SURGERY, MY LEFT EYE FELT STRANGE RIGHT AWAY, LIKE IT WAS IRRITATED MORE THAN THE RIGHT EYE AND THE VISION WASN'T AS GOOD. WITH THE POST-OP CARE I TOLD MY DOCTORS THAT MY LEFT EYE WAS ALWAYS IRRITATED, BUT THEY COULDN'T TELL WHAT WAS WRONG WITH IT, ONLY AGREE THAT IT APPEARED TO BE MORE IRRITATED THAN THE RIGHT. IT'S A YEAR AND A HALF LATER AND MY LEFT EYE STILL FEELS THE SAME PRETTY MUCH ALL THE TIME, LIKE THERE'S SOMETHING IN THE EYE, LIKE I'M WEARING A CONTACT THAT SHOULD HAVE BEEN TAKEN OUT A LONG TIME AGO. THE VISION OUT OF THAT EYE IS SOMEWHAT FUZZY AS WELL. MY DOCTORS SAY THAT THE ONLY PROBLEM THEY SEE IS THAT MY EYES ARE DRIER NOW; ABOUT 6 SECOND TEAR BREAK-UP TIME. THEY SAY THAT THE IRRITATION COULD BE CAUSED BY SENSITIVITY TO DUST, WIND, PARTICLES IN THE AIR THAT WOULDN'T HAVE IRRITATED THE EYE BEFORE WITH A HEALTHY TEAR FILM, BUT NOW DO, BECAUSE OF THE DRY EYES. AND THIS DOESN'T EXPLAIN WHY THE LEFT EYE FEELS SO IRRITATED AND HAS POORER VISION THAN THE RIGHT, EVEN THOUGH THE DRY EYE IS THE SAME IN BOTH. WHEN FIRST DEALING WITH THIS CONDITION, I BELIEVE I HAD PTSD BECAUSE I HAD SUICIDAL IDEATIONS AND HAD SERIOUS PLANS TO KILL MYSELF OF THREE SEPARATE OCCASIONS. I'VE HAD DEPRESSION BEFORE, BUT NEVER SUICIDAL THOUGHTS. THIS WAS SHOCKING AND A HORRIBLE EXPERIENCE. I AM GRATEFUL TO VISION SURGERY REHAB. I TALKED ON THE PHONE AND EMAIL AND SHARED MY FEARS AND MY EMOTIONAL DISTRESS AND I FINALLY CAME OUT OF MY SUICIDAL IDEATION PHASE. DR WAS HELPFUL IN GIVING ME EYE HEALTH INFO. LASIK CENTER

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention