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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK EYE SURGERY - ENHANCEMENT

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LASIK EYE SURGERY - ENHANCEMENT Back to Search Results
Event Date 02/13/2008
Event Type  Injury  
Event Description

I had lasik surgery in 2002. In 2008, i was advised i could have lasik enhancements because my vision had changed. I now have moderate dry eye in one eye and extreme dry eye in the other. I also experience severe pain and discomfort when i try to read, watch tv, look at a computer screen, or anything that requires me to focus. My eye surgeon has placed a permanent plug in my tear duct. I use eye drops every 30 minutes and get very little relief. It has made my life miserable. I went to a cornea specialist last week. He suggested taking fish oil and other multiple vitamins in hopes of making my eye better. I was not explained the possible complications by my eye doctor, and if i signed a consent form, it was just the same day and just prior to the enhancement procedure. If i had known the possibility of the severe dry eye, i would have never had the procedure done. I am very upset with my doctor!!!.

 
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Type of DeviceLASIK EYE SURGERY - ENHANCEMENT
MDR Report Key1078775
Report NumberMW5007718
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/19/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/19/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 07/19/2008 Patient Sequence Number: 1
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