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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 09/12/2002
Event Type  Injury  
Event Description

In 2002, i underwent bilateral lasik surgery to correct nearsightedness. The result in terms of vision were successful, but i was left with extremely dry and debilitating dry eye. Due to the dryness and extreme discomfort, i complain often of eye strain in my forehead and brows. This is extremely uncomfortable and is difficult to control. Since my surgery five plus years ago, i have continuously experienced dryness and burning. The immediate effect of my lasik and dry eye was severe depression that endured for three years post-surgery. My depression was further debilitating, resulting in my inability to care for my very young family. My mental state required me to make several treatment attempts including medication and therapy. I had no prior history of depression. I found the onset of tremendous physical pain to be shockingly hard on my psyche. I have had to learn to manage my dry eye, but cannot report any true good, comfortable "eye" days since my days prior to surgery. In order to maintain any comfort at all, i must wear windless eyewear outside at all times and sometimes inside. I use eye drops all day and often at night. I use warm compresses on my eyes twice daily to maximize oil output thus improving my tear film. I also partake in oral omega 3-6-9 supplements in a further effort to improve my tear film. A humidifier at my bedside year around also improves my nighttime dryness. Suffice it to say my experience with lasik was a disaster. Clearly i was not a good candidate for the surgery despite the fact that my vision was easily correctable. It is unfair for the fda and the refractive surgery "industry" to continue this dangerous surgery on patients who do not meet a strict criteria. Contact lens intolerance should contraindicated in this surgery.

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Type of DeviceLASIK
MDR Report Key1036134
Report NumberMW5006512
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/30/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/30/2008
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

Date Received: 04/30/2008 Patient Sequence Number: 1