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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:

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Event Date 11/14/2003
Event Type  Injury  
Event Description

I had lasik surgery in (b) (6) 2003. My doctor was (b) (6) in (b) (6). I had halos the first few days, and they slowly went away by the end of the first week. Then after about a month, i started getting halos again. This time, the halos were more like smeared light. In one eye, it is smeared one way, and in the other eye, it is smeared the other way. With both eyes open, all lights look like they have big smeared "x"s over them. Also, when looking at certain kinds of lights, like traffic lights. I see double and triple lights. The visual artifacts kept getting worse for a period of 6 months and then stabilized. I also started seeing large starbursts over bright lights like headlights. To this day i still have severe visual artifacts, especially indoors and at night. During this time, my doctor insisted that my eyes were "perfect". I tried to show him a picture of what i was seeing but he told me that i was exaggerating and said that i was a "perfectionist". He treated my issues as if they were dry eyes and put plugs in my tear ducts at every visit. This did not help with the halos and starbursts; however. I believe this might have made them worse.

 
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Brand NameNA
Type of DeviceNA
MDR Report Key1584200
Report NumberMW5014406
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/16/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/16/2010
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: 01/16/2010 Patient Sequence Number: 1
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