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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
Event Date 06/19/2008
Event Type  Injury  
Event Description

I had bilateral lasik eye procedure to correct distance vision. I awoke the next day to find that i had 20/20 distance vision, but i had lost my near vision. That was not the case prior to surgery and i do not remember being specifically warned of that possibility. I also developed dry eye, floaters, halo & glare that i was told would go away within a few months healing time. They did not. I also was not offered the option of only having one eye done at a time or was the option of monovision correction offered. I am an ultrasound technician by trade and i depend on being able to see near/computer and now i am burdened with having to wear glasses and having to pay off a huge amount of loan because i didn't want to wear glasses in the first place !! diagnosis or reason for use: improve distance vision.

 
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Brand NameLASIK
Type of DeviceNONE
MDR Report Key1134043
Report NumberMW5008080
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/24/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/24/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes

Patient TREATMENT DATA
Date Received: 08/24/2008 Patient Sequence Number: 1
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