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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 06/14/2007
Event Type  Injury  
Event Description

I want the fda to know that lasik has ruined my life. I only wish that the fda had prevented this before i jumped head first into it. I have tried on numerous occasions to contact people and let them know what kind of business this lasik surgery has turned into. It is corrupt. I can guarantee that if the true results of a properly done satisfaction survey was done, it cannot be 95%. It would probably be in the 75-80% range. You get no where when you complain about a bad outcome with this surgery, because they can't fix you. What this surgery has turned into is shameful. It falls under a system that i have named "spreading the blame". This is a common political protectant that a lot of corrupt practices use in hospitals, medical practices, and larger firms that are allowing people to get away with wrongdoing. It works like this, everyone is to blame for the wrongdoing, but you can't get your hands around no one to blame. As in lasik, it was approved by the fda, laser companies make faulty equipment, doctors are performing it, state medical boards rarely act, and you are caught in the middle crying "help", but there is no police to call to. The fda doesn't police doctors, state medical boards have regulations they have to follow, laser companies say it's user error, your doctor says it takes time to heal and if you do sue, you signed the consent form before you went in, which leaves you injured and no help available. This is how it works plain and simple. Why do you think that all the injured pts' complaints sound so similar? we call to get help from the fda who we think are in place to prevent this type of practice, but we continue to get nowhere. Please listen to what i have said.

 
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Brand NameLASIK
Type of DeviceLASIK
MDR Report Key1781740
Report NumberMW5016876
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/24/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2010
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? Yes

Patient TREATMENT DATA
Date Received: 07/24/2010 Patient Sequence Number: 1
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