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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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LASIK Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Dry Eye(s) (1814); Visual Impairment (2138); Therapeutic Response, Decreased (2271)
Event Date 05/08/2008
Event Type  Injury  
Event Description

I had lasik surgery at the lasik saddleback clinic. I still need to wear glasses regularly and to drive and i now suffer from chronic dry eye. I have been taking restasis ever since.

 
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Brand NameLASIK
Type of DeviceLASIK
MDR Report Key2280331
MDR Text Key2344714
Report NumberMW5022487
Device Sequence Number1
Product Code LZS
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 09/30/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No

Patient TREATMENT DATA
Date Received: 09/30/2011 Patient Sequence Number: 1
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