MAUDE Adverse Event Report: ALCON LABORATORIES, INC. CLEAR CARE; ACCESSORIES, SOFT LENS PRODUCT

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Pain (1994)

Event Date 01/01/2018

Event Type  No Answer Provided  

Event Description

Clear care issue here's a very long explanation of what happened to me: two years ago, when on a camping trip, i forgot to pack a contact case.I had my contacts in and my normal solution with me, just forgot my case.The camp store had a contact lens kit which came with a special case and solution.The case was odd, a little cage that fit into a canister but i didn't think anything of it.Never heard of clear care before and was totally unaware of the way it worked.I did not need anything but a case and did not have any idea of the specialness of the product or read the instructions on the box.I had my cleaner from home and now i had a case.I proceeded to clean and wear my lenses the way i normally do.Got home from trip and threw away the case as do routinely with contact cases and put my new unused bottle of clear care lens solution in my cabinet.Fast forward to this week, was hurriedly packing a travel bag to go to my parents for an emergency overnight trip and saw the small travel size contact lens solution.I had my regular case.The red lid meant nothing to me.I have other bottles with red lids/labels that don't indicate anything dangerous.My tylenol bottle had a red lid and label.I used it thinking it was normal contact lens solution.The second lens hit my eye i experienced excruciating pain.I removed the lens as quickly as i could but it¿s difficult to do in that situation.I immediately washed my eye over and over with tap water until the pain subsided.That's when i read the label, although i was entirely confused because i was jumping around reading the tiny print and it still took me a minute to understand that it was a totally cleaning system.Only after i retraced my memories to that long ago camping trip and that strange little case did i put together what had happened.Additional comments: i realize warnings on labels should be sufficient but if you want to protect people, you need another obvious indicator.Labeling is not answer.I posted my experience on social media and within an hour seven other friends of mine said they'd mixed up their bottles as well and had similar experiences of pain.Medication administered to or used by the patient: no.Outcome: called the eye doctor that was on call.She said she has had many clear care calls.When and how was error discovered: the bottle should not remotely resemble a bottle of regular contact lens solutions.It should be an entirely different shape.Patient counseling provided: unknown.(b)(6), access number: (b)(4).

• Brand Name: CLEAR CARE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCT
• Manufacturer (Section D): ALCON LABORATORIES, INC.
• MDR Report Key: 8190806
• MDR Text Key: 131588285
• Report Number: MW5082470
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1