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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOT SURE INTRALASE LASER

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NOT SURE INTRALASE LASER Back to Search Results
Event Date 05/01/2010
Event Type  Injury  
Event Description

Had custom intralase lasik performed on both eyes in may. Since have had severe dry eye, halos, floaters, starbursts, and light sensitivity. I wore contacts for years and my eyes never bothered me before. Now i am in constant pain. I have never had depression before and since lasik have fallen into a deep depression. My physician downplayed the side effects saying they were uncommon, occuring less than 1% of the time, with the newer lasers and if i had custom lasik, the change of side effects would be even less.

 
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Brand NameNOT SURE
Type of DeviceINTRALASE LASER
MDR Report Key1828643
Report NumberMW5017319
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/02/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Was Device Available For Evaluation? No

Patient TREATMENT DATA
Date Received: 09/02/2010 Patient Sequence Number: 1
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