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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
Event Date 08/24/2007
Event Type  Injury  
Event Description

I had lasik surgery at lasik plus. I have permanent eye damage and discomfort as a result. I just want to make sure this is recorded in any fact finding reports on the effects of lasik surgery, so consumers will be better informed of the percentage of complications. There needs to be an easy way for pts to report problems due to this surgery, and i think lasik doctors and centers should be required to provide annual reports and records of poor outcomes. Have been receiving medical treatment since lasik surgery date. Dose or amount: na. Diagnosis or reason for use: na.

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Type of DeviceLASIK
MDR Report Key1513500
Report NumberMW5013062
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 10/16/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/16/2009
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

Date Received: 10/16/2009 Patient Sequence Number: 1