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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 05/30/2007
Event Type  Injury  
Event Description

I had lasik surgery to my left eye and prk to the right eye in 2007 at the vision center,. I had planned to have the surgery done in 2006, but decided to pass due to my family visiting us and travel commitments. Before making the final commitment to have the eye surgery, i went through a number of tests at the vision center to ensure that i was a good candidate for the surgery. Dr and several of the other examining doctors assured me that i was good candidate for lasik surgery. Dr indicated that having lasik would reduce the time for recovery and be less painful overall. I talked myself into having the surgery and decided to go for it in the same month. I was all set to have the procedure done the morning of the same month when another dr, the surgeon performing the eye surgery, suggested to have the tests redone since it been six months from the last examination. It made sense, so after the completed examination, dr(second) informed me the left was fine for lasik surgery but he felt that i should reconsider to have prk surgery on the right eye. His reasoning was that my prescription and astigmatism were stronger on the right eye and felt that having lasik would not get the results i wanted. Secondly, he said that if later down the road i wanted to have nay corrections made, they would not be able to perform additional surgeries on the right eye because the cornea was not thick enough. This all occurred 10 minutes before the surgery was to take place. He did state it would take much longer to heal, up to 6 months - 3 months for the lasik-for the vision to achieve the desired state. At the time, i did not think it sounded like too long to wait. I spent 48 years of my life with glasses-six months was not a long time. I should have walked away and re-evaluated the length of time. I had spoken to other people who had the surgery, and they didn't have any dryness at all or if they did it only lasted a couple of weeks. My eyes were in constant pain following the surgery and lasted for months. The nerve endings were supposed to heal within 2-3 weeks, but in some cases they never return to their normal or previous state. This is something that i was not told before having the surgery. If they would have told me this i would have passed on the surgery. The bottom line is that i suffered daily with pain, dryness, and burning for almost 9 months. I experienced periods of deep anxiety, depression and the inability to sleep that began about 30 days after the initial surgery. The resulting surgery has left me with extreme night vision problems including halos, star-bright and double vision. I'm afraid to drive at night. Following the surgery, i suffered with high anxiety and depression for over 8 months, which resulted in having to take many strong medications for anxiety and depression, including 3 days in a mental facility. I still take the anti-depressant medication and suffer daily with vision problems that affect my ability to read. My job requires that i work on the computer all day. The resultant surgery almost cost me my job due to lost work days and the inability to travel. For the first 6 months following the surgery, i experienced extreme difficulty sleeping and had to take strong addictive medications, such as lorazepam - anxiety- and ambien cr sleep deprivation. It has been 21 months since the surgery and my vision is still poor in the both eyes. Additionally, more in the right eye. I meet with dr wright at the vision center in 2008. After several tests, dr(first) indicated the right eye prk surgery could not be corrected. Additional surgery to the right eye may not improve the astigmatism or the halos and star-bright conditions. Dr(first) configured a pair of eye glasses after his examination hoping that it would improve vision in the right eye, but proved useless. The story does not have a pretty ending. Prior to the surgery, my eyes were correctable with eye glasses. After surgery both of eyes maintain the astigmatism and include additional defects such as halos, star-bright, and double vision. Not to mention the visual daily strain on my eyes because of the astigmatism. Unfortunately, i was one of the few that experienced sever problems as a result of the eye surgery. The fact that no support structure was in place for patients who experienced that trauma as i did made the situation even worse. I tried to get help from lasik plus, but all they could say to me was , we are sorry. My family went through a very painful period after my surgery. I was fortunate to have a wife who prayed and comforted me through this period but after 6-7 moths of being up all night and having to stay home with me during some of the rough days, it took its toll on her as well. If it were not for my strong relationship with jesus christ and many christian brothers and sisters praying for me daily, would have most likely taken my life. Dose or amount: no medication.

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Type of DeviceLASIK
MDR Report Key1284908
Report NumberMW5009567
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/08/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2009
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

Date Received: 01/08/2009 Patient Sequence Number: 1