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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTRALASE CORP LASIK

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INTRALASE CORP LASIK Back to Search Results
Model Number INTRALASE
Event Date 04/20/2008
Event Type  Injury  
Event Description

I had lasik surgery about a year ago and now i'm experiencing "starburts" and glare at night. I had the surgery done by a very well recommended surgeon, so i didn't 'cheap it off'. The starbursts are getting worse and worse but seems to go away a little when i use lubricating drops. Please stop people from having the surgery done until they've worked all the "kinks" out of it. People are having their vision damaged. Dates of use: 2007 - 2008. Diagnosis or reason for use: terrible vision. Saddleback eye center. F: lasik surgery requires that the patient take too much responsibility for their healing. Please stop this procedure until it can be perfected!.

 
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Brand NameLASIK
Type of DeviceLASIK
Manufacturer (Section D)
INTRALASE CORP
9701 jeronimo road
irvine CA 92618 191
MDR Report Key1056867
Report NumberMW5007176
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 06/03/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/03/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberINTRALASE
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: 06/03/2008 Patient Sequence Number: 1
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