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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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LASIK Back to Search Results
Event Date 04/03/2009
Event Type  Injury  
Event Description

I had lasik at (b)(6) eye ctr in (b)(6). At one month post-op, there was an epithelial ingrowth in my right eye. He continued to try and remove it four times without any luck. He also performed an enhancement during this time, which resulted in a 1. 25 hyperopia and a 1. 25 astigmatism. I believe i was the victim of malpractice. I had to ask to be sent to a specialist. The specialist has been able to reduce the amount of farsightedness and astigmatism. I am still having trouble with the epithelial ingrowth. I suffer from nighttime starbursts, halos, decreased vision in low light, and severe higher order aberrations. I have been experiencing anxiety and the feeling of hopelessness. It tears me up inside when my (b)(6) daughter talks about her daddy's boo-boo on his eye. I believe my doctor, (b)(6) reported my lasik outcome as successful. I was not informed in a meaningful way of the risk/outcomes that were to follow. I now have fear of anyone getting near my face. I find it extremely hard to drive at night due to massive starbursts. I also see numerous moons and all other objects. Lasik has been the worst thing that has ever happened to me. I regret it every moment of every day. Please take this into deep consideration and put a stop to the lasik industry so that no one else has to go through what i and thousands of other are going through. I consider my case to be a very adverse outcome. I believe most people do not know or have not taken the time to file a medwatch. Just google it, and you will see that there are thousands of people out there and that the % of bad outcomes is much higher than reported.

 
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Type of DeviceLASIK
MDR Report Key1878198
Report NumberMW5017825
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/17/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/17/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 10/17/2010 Patient Sequence Number: 1
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