MAUDE Adverse Event Report: ALCON RESEARCH, LLC CLEAR CARE CONTACT LENS CASE FOR 3% HYDROGEN PEROXIDE SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Device Problems Defective Device (2588); Improper Chemical Reaction (2952)

Patient Problems Eye Injury (1845); Eye Pain (4467)

Event Date 08/22/2021

Event Type  Injury  

Event Description

I use clear care hydrogen peroxide contact lens solution.I put my contacts in a brand new lens case, and confirmed that i filled the solution to the proper level and did everything correctly.The next morning (well past the required 6 hours), when i put my first contact in, it burned a lot and i immediately removed it.The chemical reaction hadn't properly occurred.I re-ran the reaction for 6+ hours again, using the same lens case.When i again tried putting in my contacts in the mid afternoon, they again stung and i immediately removed them.The lens case was faulty.I confirmed that my solution was fine; it worked with a new, different lens case.Hopefully clear care didn't have many faulty lens cases, but i'm submitting this in case they did.Fda safety report id # (b)(4).

• Brand Name: CLEAR CARE CONTACT LENS CASE FOR 3% HYDROGEN PEROXIDE SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 12384704
• MDR Text Key: 268935437
• Report Number: MW5103558
• Device Sequence Number: 1
• Product Code: LPN
• 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: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 104