BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE

    MDR report key: 1040904 · Received May 10, 2008

    Report

    Report Number
    MW5006821
    Event Type
    Injury
    Date Received
    May 10, 2008
    Date of Event
    March 9, 2007
    Report Date
    May 10, 2008
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    I HAD A LASIK PROCEDURE DONE IN BOTH EYES LAST YEAR IN 2007. DOCTOR PERFORMED THE SURGERY. THE PROCEDURE I HAD IS CALLED "CUSTOM" LASIK - INTRALASE -BLADELESS-. I WAS TOLD THAT THIS IS THE SAFEST PROCEDURE. SINCE I HAD THE CUSTOM LASIK, I HAVE BEEN EXPERIENCING SEVERAL COMPLICATIONS. PLEASE SEE LIST OF COMPLICATIONS BELOW: SEVERE CHRONIC DRY EYES -I AM CURRENTLY ON RESTASIS AND HAVE 1 PLUG IN EACH EYE-. I TRIED 4 PLUGS, BUT COULD NOT HAVE 4 PLUGS BECAUSE TEARS WOULD NOT STOP FLOWING. SO I NOW HAVE A TOTAL OF 2 PLUGS -ONE IN EACH EYE-. DLK -WITH RECURRENCY-. HALOS, GLARE AND STARBURSTS MAKING IT VERY DIFFICULT TO DRIVE AT NIGHT. I STILL HAVE SOME REMAINING MIOPIA AND I AM USING GLASSES TO DRIVE AT NIGHT. I DO NOT WANT TO HAVE AN ENHANCEMENT DONE DUE TO SEVERE COMPLICATIONS. - CONTRAST SENSITIVITY. I NOW NEED READING GLASSES AND GLASSES FOR THE REMAINING MIOPIA -0.5 IN THE LEFT EYE AND 1.0 IN THE RIGHT EYE-. I HAVE NEVER HAD ANY OF THE PROBLEMS MENTIONED ABOVE BEFORE THE CUSTOM LASIK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention