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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 01/08/2009
Event Type  No Answer Provided  
Event Description

Lasik surgery. By (b)(6). Saw him 10 minutes before procedure. Initial exams performed by another ophthalmologist. The surgeon stated i may get halos with my enlarged pupils. I was not warned of common side effects but about major complications only. I now experience poor night vision, contrast difficulty, halos and starbursts mainly at night and especially while driving. I actually asked my wife to drive sometimes since depending on the location i'm driving at. Can be very dangerous for me to drive since i cannot trust my eyesight. The halos, starbursts are dynamic that i am aware of my pupils contracting and widening depending on the incoming light - from cars, streetlights, traffic lights. The aberrations become bad to severe depending on how much light hits my pupils. I used to work as a paramedic, driving myself through traffic in bad/good weather, in city and rural regions with little light. Now i am not able to do this since a life might depend on me being able to get to an address quick enough. Since i cannot trust my eyesight on how it reacts to incoming light. I am no longer able to drive an emergency vehicle.

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Type of DeviceLASIK
MDR Report Key2536441
Report NumberMW5024997
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/10/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/10/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes

Date Received: 04/10/2012 Patient Sequence Number: 1