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

Lot Number 253884F

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); No Code Available (3191)

Event Date 08/16/2015

Event Type  Injury  

Event Description

This is at least the second two 12 oz bottle package of clear care contact lens solution that i have experienced this problem with.When using the product exactly as specified in the directions and after allowing at least double the neutralization time specified my contacts burn my eye to a point that i cannot wear them again for at least a day while it heals.This occurs even after trying to rinse with another sterile saline solution.Only after soaking in sterile saline for at least a couple of hours can the contacts be worn.I assumed that i may have mixed up the special container from another brand.The container from the other brand seemed to work fine.This time there were no old containers to mix up so i know for sure that the container used is the brand new one right out of the box.I have burned my eyes previously from user error of putting the clear care solution directly in my eyes and considered that my fault.This time i am quite certain it is a problem from manufacturing.Dates of use: two or three years.Diagnosis or reason for use: recommended by optometrist for lens cleaning and disinfection.Event abated after use stopped or dose reduced? yes.Event reappeared after reintroduction? yes.

• Brand Name: CLEAR CARE 3% HYDROGEN PEROXIDE
• Type of Device: CONTACT LENS SOLUTION
• Manufacturer (Section D): ALCON
• MDR Report Key: 5018792
• MDR Text Key: 23681546
• Report Number: MW5055589
• 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
• Report Date: 08/16/2015

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: No Information
• Device Lot Number: 253884F
• Other Device ID Number: H12735-0713
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 82