CLEAR CARE CONTACT SOLUTION PLUS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-01 for CLEAR CARE CONTACT SOLUTION PLUS manufactured by Alcon.

Event Text Entries

[93718755] I used clear care contact cleaning solution. I did not put it in the contact case that was provided because mine had got broke while traveling, so i put it in a normal contact case along with my contacts. My contacts was in the solution for 2 days because i wore my glasses. When i put my contact in, i experienced extreme burning and stinging. I immediately rinsed my eye with cold water for several minutes. It has been nearly 2 hrs since the incident and my eye is now swollen, red and burning. This contact solution should be taken off the shelves. There are way to many risks of using the product. "is the product over-the-counter: yes. " quantity: 1 drop(s), frequency as needed. "how was it taken or used: eye contact. " "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. " reason for use: to clean contacts.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5073700
• MDR Report Key: 7078889
• Date Received: 2017-12-01
• Date of Report: 2017-11-30
• Date of Event: 2017-11-29
• Date Added to Maude: 2017-12-04
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: CLEAR CARE CONTACT SOLUTION PLUS
• Generic Name: SOFT (HYDROPHILIC) CONTACT LENS CARE PRODUCTS
• Product Code: LRX
• Date Received: 2017-12-01
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ALCON

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-12-01