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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 Insufficient Information (3190)
Patient Problems Visual Impairment (2138); Loss of Vision (2139)
Event Date 01/01/2007
Event Type  Injury  
Event Description

Pt describes progressive worsening of night time blinding by oncoming auto-headlights which show a stellated refractile pattern. Blinding light instantly corrected after oncoming auto passes. No delayed sight in night. No true night blindness. Dates of use: in 1999. Reason for use: myopia. In 2006 lasik in (b)(6).

 
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Brand NameUnknown Brand Name
Type of DeviceLASIK
MDR Report Key2326817
MDR Text Key18128046
Report NumberMW5022944
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
Type of Report Initial
Report Date 11/01/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/01/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 11/01/2011 Patient Sequence Number: 1
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