MAUDE Adverse Event Report: UNKNOWN COLOR CONTACT LENSES; LENSES, SOFT CONTACT, DAILY WEAR

Device Problems Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)

Patient Problems Corneal Ulcer (1796); Red Eye(s) (2038); Blurred Vision (2137); Eye Pain (4467)

Event Description

I saw a patient in my office yesterday with a corneal ulcer.She was wearing contact lenses that she bought online without a prescription.She stated that she had never seen any eye care professional in the 4 years of wearing these colored contact lenses.She ordered them from www.Ttdeye.Com.She was wearing the contact lenses for 30 days at a time and woke up yesterday with pain, redness and blurred vision in her left eye.I treated her appropriately and will see her in 3 days for followup.

• Brand Name: COLOR CONTACT LENSES
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16026959
• MDR Text Key: 306159351
• Report Number: MW5113922
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1