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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
Device Problem Insufficient Information (3190)
Patient Problem Dry Eye(s) (1814)
Event Date 02/12/2010
Event Type  Injury  
Event Description

I had lasik surgery on (b)(6) 2010. The doctor explained to me that i would have dry eyes for up to 6 months after the procedure. It has now been about 18 months since the surgery, and i still have chronic dry eyes. I put lubricant eye drops in my eyes at least a few times a day. When i reported this to the doctor at my 12-month check-up, her response was that i've probably always had chronic dry eye and i just notice it more now. I have never had a problem with dry eyes until after this surgery.

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Brand NameLASIK
Type of DeviceLASIK
MDR Report Key2247854
MDR Text Key2385210
Report NumberMW5022203
Device Sequence Number1
Product Code LZS
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 09/08/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/08/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Date Received: 09/08/2011 Patient Sequence Number: 1