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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NONE

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Event Type  Other  
Event Description

Lasik 2007. Severe dry eye since, burning, unremitting pain, 4 tear ducts plugged, blood serum drops, artificial tears, restasis, depression, post traumatic stress, on work disability since 2008. This experience has been beyond traumatic. They should ban this procedure if beforehand, there is no way to determine if you will get this. I had no previous history of dry eye or any underlying conditions.

 
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Type of DeviceNONE
MDR Report Key1069873
Report NumberMW5007517
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 04/16/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/08/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Service Personnel
Is The Reporter A Health Professional? No

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