MAUDE Adverse Event Report: ALCON CLEAR CARE CONTACT SOLUTION AND CASE

Lot Number 251144F

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Eye Injury (1845); Burning Sensation (2146)

Event Date 11/10/2015

Event Type  Injury  

Event Description

When using a fresh bottle of clear care hydrogen peroxide solution on a new contact in a new contact case, after soaking 9 hours, the contact burned upon insertion.It reddened the eye, but i was able to remove the contact and rinse the eye and contact to prevent more burning.Medical attention was not sought, but a letter was sent to the company.The company responded with a list of questions, but no add'l contact or compensation since that time.Twice more this week the same event has occurred even following the company's explicit directions.Care was taken to control all aspects of the process.The burning is severe enough to cause eye damage.It is concerning that this degree of burning takes place and the product remains on the market.

• Brand Name: CLEAR CARE CONTACT SOLUTION AND CASE
• Type of Device: CLEAR CARE CONTACT SOLUTION
• Manufacturer (Section D): ALCON
• MDR Report Key: 5236614
• MDR Text Key: 31698920
• Report Number: MW5057960
• 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: 11/16/2015

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 Expiration Date: 07/31/2017
• Device Lot Number: 251144F
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR