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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
Lot Number XX
Event Date 03/12/2009
Event Type  Injury  
Event Description

Lasik procedure. After 11 months. I have dry eye, halos, starburts, pain. I cannot work because of this. I have been to 7 doctors all have different answers and nothing has worked. I am upset with the way lasik is put forth. My doctor made it sound like this stuff will not happen to you it only happens to 1% of the people and you have healthy eyes, so you have nothing to worry about. I told him over and over, i am on a computer all day i cannot have dry eye and he told me it would be short term. (b) (6).

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Type of DeviceLASIK
MDR Report Key1593115
Report NumberMW5014594
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 01/28/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/28/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device LOT NumberXX
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Date Received: 01/28/2010 Patient Sequence Number: 1