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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
Health Effect - Clinical Codes Dry Eye(s) (1814); Eye Injury (1845); Headache (1880); Loss of Vision (2139); Anxiety (2328); Depression (2361)
Date of Event 05/21/2017
Type of Reportable Event Serious Injury
Event or Problem 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 Name
LASIK LASER DEVICE
Common Device Name
LASIK
MDR Report Key6770957
Report NumberMW5071390
Device Sequence Number13429538
Product Code LZS
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 08/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device No Information
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/05/2017
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
DAILY VITAMIN ; FISH OIL; RESTASIS; WELLBUTRIN; XANAX
Outcome Attributed to Adverse Event Hospitalization; Life Threatening; Required Intervention; Disability;
Patient Age38 YR
Patient Weight107
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