MAUDE Adverse Event Report: ALCON RESEARCH, LLC CLEAR CARE PLUS; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number 11ADJ

Device Problems Device Markings/Labelling Problem (2911); Patient Device Interaction Problem (4001)

Patient Problems Eye Burn (2523); Chemical Exposure (2570)

Event Date 07/23/2022

Event Type  Injury  

Event Description

I accidentally purchased a contact product with hydrogen peroxide in it and it had a red white and blue color to the labeling in the bottle so it looked patriotic so i wasn't drawn to the stupid warning label.This kind of a product should be held back at the pharmacy so that people have to explain to the customers what to avoid doing.Normal contact lens solution allows you to rinse the contacts when you take it out of the case before you put it in your eye and my right eye now feels terrible and it felt like a chemical burn because of the stupid hydrogen peroxide in it.I'm an rn and i just never thought there was a change to contact lens solution like this.I have an eye appointment at 2:30 now and i'm very frustrated hoping i don't have to spend the rest of my day in the emergency room after that depending on what the doctor says and if i get an email from you i will follow up on that but it also sounds like from my research that i did after my i got burned that i am not the first person and people continually are getting problems with this product and that is why i recommend that it goes behind the pharmacy desk just like pseudoephedrine.Fda safety report id# (b)(4).

• Brand Name: CLEAR CARE PLUS
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 15113257
• MDR Text Key: 296783165
• Report Number: MW5111138
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Lot Number: 11ADJ
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White