MAUDE Adverse Event Report: ALCON RESEARCH, LLC (FORMERLY KNOWN AS ALCON RESEARCH, LTD) CLEAR CARE; SCCESSORIES, SOFT LENS PRODUCTS

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems Erythema (1840); Pain (1994); Burning Sensation (2146)

Event Date 01/01/2019

Event Type  No Answer Provided  

Event Description

I was going to put my contacts in and found what i thought was a bottle of saline solution with disinfectant in my bathroom vanity.I rinsed my fingers and my right contact lens and then placed it in my right eye.Immediately i got burning stinging feeling in my eye, frantically pulled the contact out and shoved my eye under the sink water to flush.My eyeball and eyelid turned bright red and painful with lots of watering.Several hours later and the lower half of eyeball and eyelid still red and sore.The product i thought was saline solution was clear care 3% hydrogen peroxide cleaning and disinfecting solution.My wife had just bought it and i had no clue it wasn't saline for rinsing and storing contact lenses.Very deceptive marketing.I see the warning now but it is not very clear and visible without turning the bottle to see the whole sentence.Burning in right eye.Reporter's recommendations: the product container needs a danger label in big clear colorful lettering.Shape the bottle differently so they do not look like saline solution containers.(b)(6).

• Brand Name: CLEAR CARE
• Type of Device: SCCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC (FORMERLY KNOWN AS ALCON RESEARCH, LTD)
• MDR Report Key: 8922815
• MDR Text Key: 155697714
• Report Number: MW5089252
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1