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

Device Problems Device Markings/Labelling Problem (2911); Patient Device Interaction Problem (4001)

Patient Problem Eye Burn (2523)

Event Date 07/21/2022

Event Type  Injury  

Event Description

Clear care plus - forgot contact solution while visiting at a friends house, found this to borrow in the bathroom - wish i had noticed warning but didn't.The bottle looks so similar, although of course now i see the red banner at the top.End of a long day, trying to get to bed.Severe burning after putting contact in the next morning.Hoping i don't have permanent damage.Immediate burning upon inserting contact.Difficult to even get the lens out because the eye/lens was instantly watery and slick from tears.The bottle should be a distinctly different shape and style , different lid opening, not the same flip top as all saline.Maybe a kid proof turn that really gets your attention.The name should incorporate the warning.Instead of "clear care plus" which sounds like any other contact solution - it should have an entirely unique name indicating it is a special treatment.But the different style bottle is critical.(b)(4).

• Brand Name: CLEAR CARE PLUS
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 15391389
• MDR Text Key: 299747267
• Report Number: MW5111950
• 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: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Sex: Female