MAUDE Adverse Event Report: TTDEYE POLAR LIGHTS GREY BLUE; LENSES, SOFT CONTACT, DAILY WEAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Keratitis (1944); Eye Pain (4467); Swelling/ Edema (4577)

Event Date 12/22/2020

Event Type  Injury  

Event Description

Severe keratitis; wore colored lenses from (b)(6) for a few hours, vision was bothering me so i took them out.My right eye became swollen shut a day after and it was the most pain i had ever felt.Went to the doctors and he told me my if my cornea had been any more damaged, that probably would've meant vision loss.Got in contact with the company, but they never answered.I read plenty of reviews and saw i wasn't the only one with this issue.I feel hogtied and am unsure of how to move forward with this.

• Brand Name: TTDEYE POLAR LIGHTS GREY BLUE
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• MDR Report Key: 11093971
• MDR Text Key: 224593462
• Report Number: MW5098570
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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: 19 YR
• Patient Weight: 61