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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTRA LASE CORP. INTRALASE LASER WITH VISEX TRACKING

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INTRA LASE CORP. INTRALASE LASER WITH VISEX TRACKING Back to Search Results
Event Date 09/27/2007
Event Type  Injury  
Event Description

Approximately 4-6 months after i had lasik surgery i developed severe dry eye, starburst vision -more severe at night-, and decreased vision clarity. The dry eye and decreased vision clarity is intermittent, but the starburst is constant.

 
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Brand NameINTRALASE LASER WITH VISEX TRACKING
Type of DeviceINTRALASE
Manufacturer (Section D)
INTRA LASE CORP.
9701 jeronimo road
irvine CA 92618
MDR Report Key2013465
Report NumberMW5019690
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/04/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/04/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 03/04/2011 Patient Sequence Number: 1
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