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

Lot Number H14931-0618

Device Problems Product Quality Problem (1506); Chemical Problem (2893)

Patient Problems Burning Sensation (2146); Eye Pain (4467)

Event Date 03/26/2022

Event Type  Injury  

Event Description

I have used clear care contact lens cleaner made by alcon (https://clearcaresolution.Myalcon.Com) for a number of years at the recommendation of my health care provider.The cleaner consists of hydrogen peroxide and an agent that neutralizes the caustic effects of the hydrogen peroxide with the passage of time.The instructions say that lenses must be treated for a minimum of six hours, which i always do.Over the last year or so, i think they have cut back on the amount of neutralizing agent so that there is not enough of it to neutralize the amount of hydrogen peroxide that comes in the bottle.The result is that when i put my lenses in, my eyes are burned by the hydrogen peroxide.This has happened a number of times, the last time was on march 25th when my bottle of solution was more than half full.

• Brand Name: CLEAR CARE PLUS
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 13949262
• MDR Text Key: 288284892
• Report Number: MW5108585
• 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: 03/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/31/2023
• Device Lot Number: H14931-0618
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1