MAUDE Adverse Event Report: CLEAN AND CLEAR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burning Sensation (2146)

Event Date 05/18/2017

Event Type  No Answer Provided  

Event Description

Accidentally used hydrogen peroxide in eye.Contacts cleaner.Extremely deceptive bottle.Intense burning in eye.Flushed with water.Eye feels better.I'm still extremely frustrated that the bottle looks like saline contact solution.Clean and clear brand.Is the product over-the-counter: yes.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: no.Do you still have the product in case we need to evaluate it: yes.

• Brand Name: CLEAN AND CLEAR
• Type of Device: CLEAN AND CLEAR
• MDR Report Key: 6581343
• MDR Text Key: 75773435
• Report Number: MW5069899
• Device Sequence Number: 1
• Product Code: LPN
• 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: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 81