BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK

    MDR report key: 1202339 · Received October 15, 2008

    Report

    Report Number
    MW5008646
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    March 1, 2006
    Report Date
    October 15, 2008
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED LASIK ON BOTH EYES IN 2006 AT THE LASER EYE CENTER. DR OF THE EYE CONSULTANTS PERFORMED THE SURGERY. I EXPERIENCED SEVERE DRYNESS AFTER THE SURGERY. I ALSO EXPERIENCED PROBLEM DRIVING AT NIGHT AND WATCHING TV. SOME DAYS WERE GOOD AND SOME WERE BAD. WHEN THINGS STARTED GETTING REALLY BAD, I WENT BACK TO DR. AFTER SOME TESTS, HE CONCLUDED THAT MY VISION DISTORTION IS CAUSED BY A CONDITION IN THE CORNEA, SOMETHING HE TERMED AS 'KERATOCONUS'. HE ALSO MENTIONED THAT MY EYES COULD BE SUSCEPTIBLE TO EVENTUALLY SUFFER THIS CONDITION, BUT MOST LIKELY THE PROGRESSION GOT ELEVATED BY THE LASIK. HE HAS SIGNED ME UP TO PARTICIPATE IN A STUDY CALLED 'COLLAGEN CROSS-LINKING' OF THE CORNEA - AT INSTITUTE - WHERE THEY USE A COMBINATION OF VITAMIN B2 AND UV LIGHT TO STRENGTHEN THE CORNEAL MUSCLE. THIS STUDY IS MY ONLY HOPE. IF THIS DOES NOT WORK OUT FOR ME, THEN I WOULD HAVE TO CONSIDER A CORNEAL EYE TRANSPLANT ACCORDING TO DR. I SERIOUSLY REGRET HAVING DONE LASIK. I AM HOPING THAT THIS COMPLAINT WILL HELP FDA TO HELP FUTURE POTENTIAL LASIK CANDIDATES TO SERIOUSLY CONSIDER ALL OPTIONS BEFORE OPTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention