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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK PROCEDURE W/LVI R&L EYES

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LASIK PROCEDURE W/LVI R&L EYES Back to Search Results
Event Date 09/13/2002
Event Type  Injury  
Event Description

Lasik procedure exams on both eyes in 2002. I needed glasses as i could not see anything well -road signs etc- distances. I decided to check out the lasik procedure. I was told that i would love the outcome, etc. I was told that my near perfect close up sight may be affected but that would happen as i grow older anyway. Although immediately i could see very well distances, my up close vision was bad. When i went to follow up i was told that it would get better and better. My up close vision is horrible! i am now experiencing headaches; extreme difficulty seeing anything up close, need "readers" continuously. I experience moderate to severe dry eye, itching, burning and redness daily.

 
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Brand NameLASIK PROCEDURE W/LVI R&L EYES
Type of DeviceLASIK PROCEDURE
MDR Report Key1517750
Report NumberMW5013186
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 10/23/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/23/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator OTHER
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 10/23/2009 Patient Sequence Number: 1
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