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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK EYE SURGERY NONE

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LASIK EYE SURGERY NONE Back to Search Results
Event Date 07/25/2001
Event Type  Injury  
Event Description

I had lasik eye surgery in 2001 with the eye surgeon's encouragement of how well i will see post-op. Well, the vision did improve greatly, but with a price to pay. I have suffered from severe dry eyes ever since the surgery. It's 7 years later and i am still suffering from the "uncomfortableness" of dry eyes. Now, though, i have to wear glasses again because my corneas are swollen to the point of causing blurred vision again. I just went back to my optometrist to get some new glasses and he said he had never seen a lasik pt's eyes vision drop this much in only 2 years from my last glasses change. Recently, my primary care doctor did an eye test on me with my glasses on and i failed that test. This is so scary. I am back to not being able to during the day, and even worse, is my night vision. I am scared to go out at night and drive, as all lights have a star effect. Very difficult to see. Two years ago i was started on restasis and had punctal plugs put in both eyes. The restasis did not help at all. The plugs in my eyes were also a disaster, as their tops poked and scraped into my eyes. My eyes were extremely red, painful, raw, and sore with those plugs in. One fell out about 3 months later. The other one just fell out about a month ago and i am so thankful to have it out of my eye. It was 2 years of pure hell having that thing scraping my eye. My current symptoms include: feeling like i have sand in my eyes, extremely dry eyes all the time, pain, progressive blurred vision. At night, during my restless sleeping, i wake up every hour or so with my eyes in pain and even more dry than during the day. I literally pour artificial tears into my eyes all night long. When i had this procedure done, i don't remember being told that this dry eye syndrome was a risk i was taking. I wish i had never had it done. And that says a lot from someone who wore glasses all her life and was so excited to think of having surgery to help me see better.

 
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Brand NameLASIK EYE SURGERY
Type of DeviceNONE
MDR Report Key1158866
Report NumberMW5008287
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/11/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 09/11/2008 Patient Sequence Number: 1
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