MAUDE Adverse Event Report: CIBA VISION CORPORATION GENERIC; CLEAR CARE

Device Problem Insufficient Information (3190)

Patient Problem Burning Sensation (2146)

Event Date 01/01/2015

Event Type  Other  

Event Description

Description: i use clear care contact solution on a daily basis and have for about 5 years.It is great for cleaning my contact lenses.The problem is that they will randomly not neutralize sometimes and i get the burn on my fingers and my eye.No, a am not one of those people who can't read directions.I let them soak in the solution for at least 7-8 hrs every night.This morning i went to put them in, and they burned my finger and thumb and my eye that i had put the lens in.This is very frustrating as i did nothing different and there is no way to tell when this will happen.I don't know if the disc wears out or what, but i'm getting tired of worrying about putting my lenses in my eyes in the morning because it's not pleasant when they burn.Pt's age: 18-64 years.Reporter recommendations: they need to warn customers about the possibility of the lens cleaner randomly, not neutralizing properly.(b)(6).

• Brand Name: GENERIC
• Type of Device: CLEAR CARE
• Manufacturer (Section D): CIBA VISION CORPORATION
• MDR Report Key: 4888374
• MDR Text Key: 6072564
• Report Number: MW5043479
• 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: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2015
• Patient Sequence Number: 1