MAUDE Adverse Event Report: JOHNSON AND JOHNSON/ ALCON CLEAN AND CLEAR 3 PERCENT HYDROGEN PEROXIDE TRIPLE ACTION; ACCESSORIES SOFT LENS PRODUCTS

Device Problem Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2017

Event Type  No Answer Provided  

Event Description

Need to label clean and clear peroxide cleanser better.A red cap is not enough.I thought this was a regular solution for my contacts and placed it directly in my eye.It needs to be labeled on the box and better on the cap that the product does not go directly on eyes.Also it would be helpful if the box stated disinfectant instead of cleanser.That can make people confused.Date the person first started taking or using the product: (b)(6) 2017.Date the person stopped taking or using the product: (b)(6) 2017.

• Brand Name: CLEAN AND CLEAR 3 PERCENT HYDROGEN PEROXIDE TRIPLE ACTION
• Type of Device: ACCESSORIES SOFT LENS PRODUCTS
• Manufacturer (Section D): JOHNSON AND JOHNSON/ ALCON
• MDR Report Key: 7138449
• MDR Text Key: 95721015
• Report Number: MW5074151
• 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: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 68