MAUDE Adverse Event Report: ALCON CLEAR CARE TRIPLE ACTION CONTACT LENSES SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Device Problem Improper Chemical Reaction (2952)

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

Event Date 06/05/2018

Event Type  Injury  

Event Description

I used container what came with my previous bottle to put lenses in solution for overnight.It did not neutralize the peroxide after about 10 hrs and cause severe burning and eyes redness for 3 days.I had to go to eye dr to get solution to help my red eyes.

• Brand Name: CLEAR CARE TRIPLE ACTION CONTACT LENSES SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON
• MDR Report Key: 7591203
• MDR Text Key: 110936034
• Report Number: MW5077782
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2019
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 68