MAUDE Adverse Event Report: ALCON RESEARCH, LLC. CLEAR CARE PLUS 3% HYDROGEN PEROXIDE; ACCESSORIES, SOFT LENS PRODUCTS

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

Patient Problems Red Eye(s) (2038); Eye Burn (2523)

Event Date 11/12/2022

Event Type  Injury  

Event Description

My regular contact solution that i buy was sold out so i ended up purchasing a different brand.I purchased the clear care plus 3% hydrogen peroxide solution thinking it was contact solution.The box is blue with a picture of a contact lens on it, identical to how regular contact solution looks.There is a very small warning on the box, which is a photo of the small red label on the bottle.However, as a contact wearer for 10+ years, i do not ever feel the need to read the label given this is a product i have used regularly for years.I did notice the top of the bottle was red, but with it being a different brand than i usually use, i thought nothing of it.I used it as regular contact solution, and upon putting my contact back in my right eye i immediately experienced a severe burn.Still not realizing that i had used 3% peroxide, i went to urgent care (for a (b)(6) copay) and was given antibiotic eyedrops (which cost me (b)(6)) for what was presumed a corneal abrasion.It was not until the next morning that i noticed the warning label on the bottle of 3% peroxide and realizing that i gave myself a chemical burn on my cornea.Upon doing some research, i have come to learn that this has been an extremely common misuse of this product, as i'm able to find articles about the matter dating back over 10 years with calls to create more obvious warnings on the product.Given that the box and bottle look identical to regular contact solution, aside from a small red label, this mistake is still extremely easy to make.It is currently 3 days later and i have not been able to wear contacts again, my eye is improving but is still red and irritated from the chemical burn.

• Brand Name: CLEAR CARE PLUS 3% HYDROGEN PEROXIDE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC.
• MDR Report Key: 15825632
• MDR Text Key: 304026424
• Report Number: MW5113350
• 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: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White