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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK SURGERY

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LASIK SURGERY Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Dry Eye(s) (1814); Pain (1994)
Event Date 06/24/2011
Event Type  Injury  
Event Description

Lasik surgery to left eye. Prior vision 20/20-2 in the left eye. Prior dry eye due to medications. Told he was a candidate for lasik mono vision. Surgery done on left eye. Vision now 20/400, pain, severe dryness.

 
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Type of DeviceLASIK SURGERY
MDR Report Key2329769
MDR Text Key17103282
Report NumberMW5022993
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 11/03/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/03/2011
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

Patient TREATMENT DATA
Date Received: 11/03/2011 Patient Sequence Number: 1
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