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

Device Problems Product Quality Problem (1506); Chemical Problem (2893); Output Problem (3005)

Patient Problem Eye Injury (1845)

Event Date 10/05/2021

Event Type  Injury  

Event Description

I've been using clear care contact solution for almost 20 years, without major issue.Over the past year or so it seems like it has been taking longer and longer for the solution to neutralize.I always use a new case and throw out the old one when i get a new bottle.But lately, it's directed 6 hour time is nowhere near enough.In fact after i bought my last pack (which is a two pack of bottles with one case), the first night i left my contacts in the solution for over 24 hours and it still did not fully neutralize.I have noticed that the last several cages looked to have a much thinner titanium dioxide coating on the neutralizing disk.You can clearly see plastic underneath, which is not completely abnormal for a case at the end of it's lifecycle, but this is happening on newer cases and i believe that may be resulting in a slightly smaller surface area and therefore not neutralizing nearly as fast.Obviously this is an issue because it burns my eyes, that is unless i rinse, then soak (for about 10 minutes), then rinse the contacts again in saline solution, which kind of defeats the purpose of the clear care, unless you need your contacts disinfected.Fda safety report id# (b)(4).

• Brand Name: CLEAR CARE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC.
• MDR Report Key: 12615893
• MDR Text Key: 276241272
• Report Number: MW5104531
• Device Sequence Number: 1
• Product Code: LPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 104