MAUDE Adverse Event Report: ALCON CLEAR CARE 3 PERCENT HYDROGEN PEROXIDE TRIPLE ACTION CLEANING

Lot Number 279632F

Device Problem Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problem Pain (1994)

Event Date 10/09/2017

Event Type  Injury  

Event Description

I bought new contact solution because my contact was bothering me and i wanted to take it out.I chose the clear care solution because it came with a case.It did say on the box front it had hydrogen peroxide.I read the directions but felt they were not very clear that the contacts should not be taken out and used for at least 6 hours.I thought the 6 hours was referring to how long it would taken to fully disinfect the lens.It even says the lenses do not need to be rinsed with saline and can be put directly in your eye.The only warning label was on the back of the box at the very bottom.I ended up putting one of my contacts in after 30 minutes in the solution which followed with the most intense pain i've ever felt that lasted over 24 hours.I don't understand why there is no warning banner across the front of the box.The only other warnings on the box were written on the inside of the box.Who opens something and reads what's written on the inside of a box? for someone who is newer to wearing contacts like myself, their needs to be better warnings.I feel like this is a very easy mistake to make that could easily be rectified with a simple red banner warning across the front of the box.Is the product over-the-counter: yes.Strength: 3 percent hydrogen peroxide.Quantity: other.Frequency: as needed.How was it taken or used: ophthalmic.Date the person first started taking or using the product: (b)(6) 2017.Date the person stopped taking or using the product: (b)(6) 2017.Did the problem stop after the person reduced the dose or stopped taking or using the product: yes.Did the problem return if the person started taking or using the product again: doesn't apply.Why was the person using the product: to store/clean contact lens.

• Brand Name: CLEAR CARE 3 PERCENT HYDROGEN PEROXIDE TRIPLE ACTION CLEANING
• Type of Device: CLEAR CARE 3 PERCENT HYDROGEN PEROXIDE TRIPLE ACTION CLEANING
• Manufacturer (Section D): ALCON
• MDR Report Key: 6950942
• MDR Text Key: 89520994
• Report Number: MW5072756
• 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: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/30/2018
• Device Lot Number: 279632F
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 72