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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK NONE

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LASIK NONE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Dry Eye(s) (1814); Blurred Vision (2137); Visual Impairment (2138); Loss of Vision (2139)
Event Date 10/11/1997
Event Type  Injury  
Event Description

Dr. (b)(6) performed a failed lasik surgery. Symptoms resulting from operation include dry eye, blurry vision, reduced vision, poor night vision, unable to wear contacts or correct vision with glasses. (b)(6).

 
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Brand NameLASIK
Type of DeviceNONE
MDR Report Key2281654
MDR Text Key2348864
Report NumberMW5022517
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 10/03/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/03/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No

Patient TREATMENT DATA
Date Received: 10/03/2011 Patient Sequence Number: 1
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