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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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Event Date 09/24/2009
Event Type  Injury  
Event Description

I had lasik in 2006 and since the surgery, i continue to have dry eyes, and occasionally my eyes are red almost look like the pink eye. I recently was diagnosed with corneal erosion of the eye flap and was instructed by my eye doctor to return to the lasik doctor for further treatment. The physician at the lasik facility stated that it was a small erosion and i should not be worried and to follow-up in 3 months. The redness occurred a few years ago, and i did not know why and now i do. Lasik plus. Diagnosis or reason for use: corneal erosion.

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Type of DeviceLASIK
MDR Report Key1527201
Report NumberMW5013480
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 11/09/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/09/2009
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: 11/09/2009 Patient Sequence Number: 1