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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 06/24/2005
Event Type  Injury  
Event Description

I had lasik performed on both eyes in 2005. My surgery was done by a dr. I wanted lasik because i was no longer comfortable wearing contact lenses. I was not tested for dry eye or warned of the link between contact lens intolerance and dry eye. I was also not warned that a pre-existing dry eye condition would put me at a higher risk for developing permanent dry eye after surgery. I was handed my informed consent form with the words "read this, but don't let it scare you, this stuff never happens. " immediately following my surgery, i began having pain in both eyes due to severe dry eye. My lasik clinic offered very little help, and when i was able to get visits with my surgeon -instead of the regular post-op care dr-, he would spend about 2 minutes with me and rush me out the door to perform his next "assembly line" lasik procedure. I have seen over 10 doctors, tried most conventional dry eye treatments, and spent thousands of dollars in the process trying to get relief from dry eye pain and discomfort. I continue to spend over $100 a month on drops, gels, and other treatment methods to help with my condition. That said, i am still always uncomfortable and often in pain due to my lasik-induced severe dry eye. My dry eye symptoms have impacted all aspects of my life and affect me every waking hour. The first year after my surgery was complete torture. I suffered from severe depression and panic attacks due to the physical pain and guilt that i felt over having elected to have lasik. I never had a problem with anxiety or depression prior to my lasik outcome. A 15 minute procedure that was supposed to make my life easier, has now greatly decreased my quality of life and has complicated it more than i ever could have imagined. I will face a lifetime of eye pain and problems due to my lasik outcome. I cannot express in words the pain and sadness that lasik has caused me and those closest to me. I try to keep hope that someday a new drug will come out that will help me, but until that day comes, i will continue to battle eye pain and the altered lifestyle that i have been forced to accept under these circumstances. I am unsure what laser was used to perform my surgery.

 
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Type of DeviceLASIK
MDR Report Key1055489
Report NumberMW5007093
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/30/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/30/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 05/30/2008 Patient Sequence Number: 1
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