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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK PROCEDURE

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LASIK PROCEDURE Back to Search Results
Event Date 04/15/2003
Event Type  Injury  
Event Description

Had lasik procedure for vision correction. Resulted in severe debilitating dry eye in right eye. Also moderate to severe dry eye in the left. Was informed that dry eye was a temporary condition, and would subside in a few weeks. Resulted in poor to extremely blurred vision in the right eye. Glasses will not help due to varying extremes in vision affected by the dry eye. Had no preexisting condition going into surgery, nor was any exam given for existing moisture conditions. Reported this to place that i had surgery done and was told it may take a year or more for it to subside. Duration of time became longer than first information i received. Was on restasis for about 1 year. This had no positive effect on the condition. Condition is painful, and exceptionally bad during the winter months when dryer outside. Can not tolerate air movement of any kind toward eyes. Results in instant irritation and heightened blurring of right eye. Must put drops in 20 times a day or more.

 
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Type of DeviceLASIK PROCEDURE
MDR Report Key1387958
Report NumberMW5011166
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 05/18/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/18/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 05/18/2009 Patient Sequence Number: 1
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