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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK NONE

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LASIK NONE Back to Search Results
Lot Number NONE
Event Date 12/11/1993
Event Type  Injury  
Event Description

Rk surgery done by dr (b)(6) i started wearing glasses in 7th grade -1974. In 1993 -(b)(6) started doing research into the rk surgery. I made an appt with dr (b)(6) to discuss if the rk surgery was right for me. Dr (b)(6) assured me that i was a perfect candidate for the rk surgery and dr (b)(6) assured me that i would have no problems after the procedure was completed and also assured me that if he even thought that there would be any problems that he would not consider doing the surgery. Dr (b)(6) also told me that once the procedure was done, i would never have to wear glasses again. At that time i felt very confident about the surgery and dr (b)(6) and i decided to have the rk surgery done. Once the procedure was done, i opened my eyes and was amazed to find out that i was able to see across a room without my glasses. Approx two weeks later, i went back to see dr (b)(6) for a f/u appt, and it was at that time i shared my concerns with him regarding my eyes. I told dr (b)(6) that i was experiencing soreness in both eyes and that both of my eyes were constantly watering. He assured me at that time that those were signs of healing and that i didn't need to be concerned. Between 1993-1998, my one eye became constantly dry while the other eye was always watering. I started experiencing some blurriness in both eyes and whenever i would look directly into a bright light i could see the pie cuts in my eyes. Between 1999-2002, the blurriness in my eyes was slowly getting worse and i was still experiencing dryness in my one eye, and the other eye watering all of the time. By 2006, my right eye went completely blurry and at that point i made an appt with dr (b)(6) -eye specialist. Dr (b)(6) told me i had a water blister on my right eye and that it may or may not clear up in time. By 2010, i started noticing that my eyes were deteriorating rapidly and i went back to see dr (b)(6). Dr (b)(6) put me back in glasses -but they didn't work for me. Dr (b)(6) currently has me using contact lenses which are helping a little bit, but they are not correcting my problem. I am slowly going blind and was told there is nothing that can be done to correct the damage that was done by dr (b)(6) in 1993. I am a (b)(6) contractor, i have never been married nor do i have any children. I am self employed which is my only means of support. Once i have totally lost my eye sight, which i have been told is a very short time away, i have no means of income.

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Brand NameLASIK
Type of DeviceNONE
MDR Report Key1897291
Report NumberMW5018085
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/03/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/03/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Device LOT NumberNONE
Is The Reporter A Health Professional? No

Date Received: 11/03/2010 Patient Sequence Number: 1