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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:

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Event Date 01/15/2010
Event Type  Injury  
Event Description

I had custom lasik surgery (b)(6)2010. I was high prescription -8. 5 near-sighted with astigmatism. Prior dry-eye issues, but not extreme. Very active. A 15-year vegetarian. Since surgery, i have never seen clearly again. It is scary to drive at night since i cannot see street signs or turns until it's too late to turn or completely miss the turn, and i have almost caused 4 car accidents. I experience double vision, blurry vision, weird focusing problems with movement or near-to-far, headaches, and dry eyes all the time. My left eye - i can see, but it is inferior to contacts, only with good light when not experiencing the other problems. My right eye - has never been clear. The right is always blurry near or far and, i experience more problems with double vision and dryness etc. I have gone back several times for examination as to my blurriness, etc and am told there is nothing they can find. It has been almost a year now with no resolution. I continue to use eye drops -their suggestion- often which do not give any real relief to the problems i experience and advil doesn't help the headaches as they are caused by weird focusing issues that make me dizzy and tired. When in crowds of people i feel self-conscience since i cannot see, especially at an evening event. When going to (b)(6) or shopping i cannot see (b)(6) labels until walking down the aisle. When i'm tired or my eyes feel dry, it's much worse and can last for a constant of several days. I have tried taking more vitamin a, zinc, omega 3 and omega 6, protein, but all have not significantly improved anything. Overall, i wish i never had the surgery. I have all the problems of contacts, but feel that i will never see clearly again for the rest of my life.

 
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Brand NameNA
Type of DeviceNA
MDR Report Key1842497
Report NumberMW5017489
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/19/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/19/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 09/19/2010 Patient Sequence Number: 1
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