MAUDE Adverse Event Report: COLEYES NONNO RED VAMPIRE PRESCRIPTION YEARLY COLORED CONTACTS; LENSES, SOFT CONTACT, DAILY WEAR

Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There is an advertisement online that states: "fda approved cosplay contacts - ship within 24 hours" for prescription halloween colored contacts.I was able to order my contacts without providing a prescription (i wear a 5.5 lens but they did not have that script and i ordered a 6 and this was allowed), and when the tracking information was provided, i noticed this was coming from china.How does china have fda approval, and why are they providing prescription contacts for sale without verifying prescriptions.I have not received the contacts, but i am concerned about the quality.The site does not represent these are from china, and i thought it was legitimate due to the fda approved message in the ad online.Last year i bought prescription contacts from china, and it may have even been this site.After sitting in saline solution for a day, the saline turned the color of the contact which was red.That cannot be good when the color of the dye is bleeding into saline water.Those are going in my eyes.I was trying to avoid that this year, and was unpleasantly surprised when i got shipping info leading to china.Coleyes.

• Brand Name: COLEYES NONNO RED VAMPIRE PRESCRIPTION YEARLY COLORED CONTACTS
• Common Device Name: LENSES, SOFT CONTACT, DAILY WEAR
• MDR Report Key: 17967210
• Report Number: MW5147115
• Device Sequence Number: 19128855
• Product Code: LPL
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2023
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian, White