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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TTDEYE POLAR LIGHTS BROWN COLOUR CONTACT LENSES

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TTDEYE POLAR LIGHTS BROWN COLOUR CONTACT LENSES Back to Search Results
Model Number TTDEYE POLAR LIGHTS BROWN
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Corneal Abrasion (1789)
Event Date 10/24/2018
Event Type  Injury  
Event Description
Hi, i bought 2 pairs of color contacts from (b)(6). They claimed that they will verify my prescription with my doctor, but they did not. In the end they send me the lens i ordered without any verification done. So it end up send me wrong bc lenses and both company lenses made my eye corneal abrasion after wearing their lenses in halloween party last year. I would like fda to take action against sellers that do not verify customer color contacts prescriptions. They need to regulate this, so no more people will get hurt.
 
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Brand NameTTDEYE POLAR LIGHTS BROWN
Type of DeviceCOLOUR CONTACT LENSES
MDR Report Key8281679
MDR Text Key134521441
Report NumberMW5083421
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/24/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTTDEYE POLAR LIGHTS BROWN
Device Catalogue NumberTTDEYE POLAR LIGHTS BROWN
Device Lot NumberTTDEYE POLAR LIGHTS BROWN
Was Device Available for Evaluation? Yes
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: 01/25/2019 Patient Sequence Number: 1
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