MAUDE Adverse Event Report: ALCON RESEARCH, LLC CLEAR CARE PLUS 3% HYDROGEN PEROXIDE; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number 10JH2

Device Problems Labelling, Instructions for Use or Training Problem (1318); Patient-Device Incompatibility (2682)

Patient Problems Eye Burn (2523); Caustic/Chemical Burns (2549); Eye Pain (4467)

Event Date 07/16/2021

Event Type  Injury  

Event Description

Chemical burn in eye; i stayed at a family member's house and looked under the sink for saline solution.I grabbed the bottle that looked exactly like saline solution and put a drop in my eye because my eyes were very dry.It caused excruciating pain and i flushed my eye for hours.This product should not be sold in its current packaging as it looks exactly like saline solution and the warning on the bottle is not sufficient.The packaging should only be able to dispense the solution into the appropriate case (there is apparently only one case that can be used with this solution or burning of the eye will occur).I thought it was saline solution.

• Brand Name: CLEAR CARE PLUS 3% HYDROGEN PEROXIDE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 12202409
• MDR Text Key: 262889720
• Report Number: MW5102637
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): Y
• 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: 07/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2023
• Device Lot Number: 10JH2
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR