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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTRALASE LASER LZS INTRALASE LASER

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INTRALASE LASER LZS INTRALASE LASER Back to Search Results
Event Date 06/08/2006
Event Type  Injury  
Event Description

For the first 2 weeks after lasik, my eyes felt a little dry, but overall good. However, over the next few weeks, the dryness kept getting worse. By week 6, i had severe lasik induced nerve damage dry eyes. My eyes were bone dry and the pain was unbearable for the first 10 months post-lasik. I could feel the pain with every blink of every day. Even closing my eyes provided minimal relief. All the eye doctors could do was tell me to keep using artificial tears, put me on restasis, and put plugs in my puncta -the drains of the eye-. These things provided minimal relief. The pain was so intense with so little relief from existing therapies that i found myself researching suicide options on the internet. Prior to lasik, i was a happy family man with a good job. To think that i could find myself in this type of position because of lasik, an unnecessary fda approved procedure, was beyond belief. I am now over 2 years post-lasik and i suffer from senseless, permanent disabilities incurred from lasik. There are many things that i no longer can do such as being in a room with moving air from ceiling fans, heating vents, or air conditioning. I can only work limited hours due to the chronic post-lasik pain that i endure. I suffer from chronic eye pain that intensifies as the day goes on. I would write more but i don't think anyone in the fda who has any decision making authority reads these reports because if they did, i would expect that they would feel a shock to their conscience that the fda continues to allow people's eyes and lives to be ruined by lasik, a senseless, non-medically necessary procedure. I've heard lasik physicians compare lasik to other cosmetic procedures. That's absurd! if somebody has a poor outcome with breast augmentation, they can still go to work and/or drive at night. A person's eyes are their most vital sensory organ. If you damage a person's eyes, you damage that person in the most significant way. While it's too late for me and many others, it's not too late for future lasik pts. I request that the fda serve the public that you are entrusted to protect rather than serving the lasik industry.

 
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Brand NameLZS
Type of DeviceINTRALASE LASER
Manufacturer (Section D)
INTRALASE LASER
MDR Report Key1135383
Report NumberMW5008096
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/25/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/25/2008
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

Patient TREATMENT DATA
Date Received: 08/25/2008 Patient Sequence Number: 1
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