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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNK MFR CONTACT LENSES

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UNK MFR CONTACT LENSES Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Ulcer (2274)
Event Date 01/31/2017
Event Type  Injury  
Event Description
I am an optometrist and i have had several patients come in my office with infections and ulcers. These new patients were buying colored contact lenses from beauty supply stores and flea markets in the (b)(6) area. One of the stores is (b)(6) in (b)(6). They are also using fda labels on the cases to make it seem authentic. (b)(6).
 
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Brand NameCONTACT LENSES
Type of DeviceCONTACT LENSES
Manufacturer (Section D)
UNK MFR
MDR Report Key6300725
MDR Text Key66595345
Report NumberMW5067655
Device Sequence Number1
Product Code LPL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2017
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/01/2017 Patient Sequence Number: 1
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