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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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Event Type  Injury  
Event Description

I had lasik on my right eye and soon after developed large floaters. In addition, i have had five retinal detachments in the eye and may end up legally blind in the eye. Lasik on right eye in 2000.

 
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Brand NameLASIK
Type of DeviceLASIK
Device Event Key2550772
MDR Report Key2520927
Event Key2417681
Report NumberMW5024883
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/02/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 04/02/2012 Patient Sequence Number: 1
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