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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONTACT LENSES

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CONTACT LENSES Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Conjunctivitis (1784); Corneal Edema (1791); Neovascularization (1978)
Event Date 12/03/2013
Event Type  Injury  
Event Description

This pt states ordered contact lenses from 1800 contact lenses. She states that she was able to purchase the contact lenses for the last 7 years without a valid prescription. The pt has corneal edema (eye swelling), which is preventing her from seeing 20/20. She has corneal neovascularization and giant papillary conjunctivitis.

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MDR Report Key3535876
MDR Text Key4114614
Report NumberMW5033569
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 12/17/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/18/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator
Is The Reporter A Health Professional? Yes

Date Received: 12/18/2013 Patient Sequence Number: 1