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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK LASER DEVICE

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LASIK LASER DEVICE Back to Search Results
Event Date 05/21/2017
Event Type  Injury  
Event Description

Had lasik surgery in 2001, at (b)(6) y/o and "was a perfect candidate doctor (b)(6) said. " had severe corneal ectasia went blind after. Had corneal transplant in 2003. Lens implanted in 2004. Many subsequent surgeries since. Lasik completely destroyed my life. I have lost years of work as a deputy sheriff and was taken off the street due to vision. I have held my service revolver to my head several times contemplating suicide. I have daily debilitating headaches and severe dry eyes. I have even had my blood made in eye serum drops out of desperation for my eyes. Nothing works including many specialty contact fitting attempts. I am more suicidal than ever and know it will happen when i get the courage to do so. The lasik doctors knew this surgery was extremely dangerous but didn't care because it was a billion dollar industry. They lied to the fda minimizing the side effects (the fda board chairman who approved lasik later testified to this) and complications of this surgery. Lasikplus informed me the worst side effect of this surgery was slight glare and dry eyes which would go away within a year. That was blatant lie and they knew it.

 
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Brand NameLASIK LASER DEVICE
Type of DeviceLASIK
MDR Report Key6770957
Report NumberMW5071390
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/05/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/05/2017
Is This An Adverse Event Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/05/2017 Patient Sequence Number: 1
Treatment
DAILY VITAMIN
FISH OIL
RESTASIS
WELLBUTRIN
XANAX
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