MAUDE Adverse Event Report: ALCON/NOVARTIS CLEAR CARE 3% HYDROGEN PEROXIDE; CONTACT LENS CLEANING SOLUTION

Device Problem Inadequate Instructions for Non-Healthcare Professional (2956)

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

Event Date 10/26/2015

Event Type  Injury  

Event Description

Used clear care contact lens cleaner 3% hydrogen peroxide solution.Product does not take adequate steps to label.Upon placing the lens in the eye without neutralizing solution (very easy to do as the bottle is packaged in a manner similar to other products that do not need to be neutralized) i received chemical burns to my cornea.Currently unable to see or work until cornea heals.Diagnosis or reason for use: contact lens cleaning and disinfecting.Event abated after use stopped or dose reduced, yes.

• Brand Name: CLEAR CARE 3% HYDROGEN PEROXIDE
• Type of Device: CONTACT LENS CLEANING SOLUTION
• Manufacturer (Section D): ALCON/NOVARTIS
• MDR Report Key: 5191535
• MDR Text Key: 30021289
• Report Number: MW5057579
• 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: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 98