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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COSMETIC CONTACT LENS NONE

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COSMETIC CONTACT LENS NONE Back to Search Results
Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)
Patient Problem Red Eye(s) (2038)
Event Date 11/29/2013
Event Type  Injury  
Event Description

The pt developed bilateral red eyes secondary to a cosmetic contact lens obtained from halloween usa in (b)(4) without a valid prescription. Dates of use: (b)(6) 2013. Diagnosis or reason for use: cosmetic contact lens for halloween costume. Event abated after use stopped: yes.

 
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Brand NameCOSMETIC CONTACT LENS
Type of DeviceNONE
MDR Report Key3458661
MDR Text Key3941473
Report NumberMW5032612
Device Sequence Number1
Product Code LPL
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 11/04/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/07/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes

Patient TREATMENT DATA
Date Received: 11/07/2013 Patient Sequence Number: 1
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