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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTRALASIK

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INTRALASIK Back to Search Results
Event Date 06/28/2007
Event Type  Injury  
Event Description

Had lasik surgery in 2007 in both eyes. Left eye problems include massive starbursts at night, halos, dry eye, eye callous, ctk, folds, skin ingrowth near flap, pterygium. Right eye problems severe dry eye, halos, glare, minor starbursts. Lasik re do surgeries (b)(6) 2007, (b)(6) 2007 and (b)(6) 2008.

 
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Brand NameINTRALASIK
Type of DeviceINTRALASIK
MDR Report Key1951972
Report NumberMW5018873
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/03/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/03/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 01/03/2011 Patient Sequence Number: 1
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