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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC FRESH COLORBLENDS LENSES, SOFT CONTACT, DAILY WEAR

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ALCON RESEARCH, LLC FRESH COLORBLENDS LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Model Number UPC: 7-30821-59898-0
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Visual Impairment (2138)
Event Date 06/05/2021
Event Type  malfunction  
Event Description
Vision was impaired; on may 31st i decided to try out a new company that listed cheaper prescription contact lenses. There was a 4 step process to confirm the order. The second step was payment info. On that page, i noticed that they needed to contact my eye doctor and i exited the page. My plan was to let the weekend and holiday pass so that i could call my doctor for instructions on ordering from them. Almost as soon as i left the page i got a receipt in my email for contact lens. I had no clue if the order was because i left the page and didn't confirm the order. My doctor's office was not open on may 31st to verify the prescription. I called them at (b)(6) and sent emails to tell them that i did not confirm the purchase but got no response. Even though i didn't get a response they made sure to let me know when the order was shipped and how to track it. I contacted my bank to make them aware of the situation and that i wanted my money refunded. Finally, someone called me back on tuesday and said they would send a pre-paid label to send them back for a refund. When the contacts arrived on june 5th, i was going to keep them as an extra set because i already placed an order with my usual company, (b)(6). I tried (b)(6) contacts lens while wearing my current lens to find that they were just color lens. They are label as a prescription but the box is different from what i normally get. I packaged it up after taking pictures. I was going out to drive and could have gotten into an accident because i couldn't see out of their 1 lens. Fda safety report id# (b)(4).
 
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Brand NameFRESH COLORBLENDS
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
ALCON RESEARCH, LLC
MDR Report Key11965763
MDR Text Key255392287
Report NumberMW5101767
Device Sequence Number1
Product Code LPL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUPC: 7-30821-59898-0
Device Catalogue NumberOL3719268
Device Lot NumberVER: 01/ 31414643
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: 06/08/2021 Patient Sequence Number: 1
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