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

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.

• Brand Name: TTDEYE POLAR LIGHTS BROWN
• Type of Device: COLOUR CONTACT LENSES
• MDR Report Key: 8281679
• MDR Text Key: 134521441
• Report Number: MW5083421
• 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: 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 Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/18/2023
• Device Model Number: TTDEYE POLAR LIGHTS BROWN
• Device Catalogue Number: TTDEYE POLAR LIGHTS BROWN
• Device Lot Number: TTDEYE POLAR LIGHTS BROWN
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Weight: 65