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

Device Problems Product Quality Problem (1506); Improper or Incorrect Procedure or Method (2017)

Patient Problems Red Eye(s) (2038); Burning Sensation (2146)

Event Date 07/09/2019

Event Type  Injury  

Event Description

I use clear care contact lens cleaner (https://clearcaresolution.Myalcon.Com).I used it appropriately last evening.This morning i went to put my contact lenses in.Right lens went in fine.I dropped my left lens and needed to rinse it.I was thinking about my day and not paying attention.I picked up the bottle of clear care and rinsed my lens, then put it in my left eye.Severe burning resulted, to the point i couldn't open my eye to remove the lens.I quickly began flushing my eye with normal saline solution, but the damage was done.Eventually the left lens fell out.Severe burning and redness continued.Severe burning continued for about 2 hours; milder burning persists now as i write this, 4 hours later.Marked bulbar and palpebral conjunctival injection.Afterwards, the left eye felt extremely dry.I went to work with only a right lens in.Conjunctival injection of left eye persists now 4 hours later.I should probably patch my eye, but i need to work today.I should mention, i am a med dr.I feel strongly that the packaging of this product is defective.Why is the bottle the exact same size and shape of contact lens saline bottles? and why does the bottle have a flip-top squirter exactly the same size, shape, and feel of other saline contact lens solutions? having a red tip on the bottle is not adequate warning of the severe pain and potential injury that can occur from the distracted use of this product.My strong feeling is that the size and shape of the bottle must be changed to prevent further consumer injury, and that the design of the tip must be changed as well so that there is no possible way that a bottle of clear care can be mistaken for a bottle of saline contact lens solution.In the meantime, while the bottle is being redesigned, there should be instructions on the bottle about treatment of the chemical burn that can result from the mistaken use of this product.I read the bottle afterwards and there is no info about mgmt of a conjunctival chemical burn caused by hydrogen peroxide.Reason for use: to clean and disinfect contact lenses.

• Brand Name: CLEAR CARE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC.
• MDR Report Key: 8780675
• MDR Text Key: 150994647
• Report Number: MW5088020
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): Y
• 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: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 89