MAUDE Adverse Event Report: CIBA VISION CLEAR CARE

Lot Number 20379

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Pain (1994)

Event Date 03/31/2014

Event Type  Injury  

Event Description

I purchased clear care contact solution knowing very well that contacts needed to stay in the solution for several hours before they can be worn.I've used this product before and hoped that the formula had changed (the last time i used this product several years ago, after a few weeks, no matter how long i left my contacts in the solution, it would still burn my eyes terribly).I decided to give it another try.The solution worked great for a couple of weeks and my contacts felt like new when i put them in.Last night, i took my contacts out at about 11:30 pm and woke up this morning at 9:15 am.I waited until about 10:00 at put my contacts in, and when i did, i felt the same awful burning pain that i felt so many years ago.My eye shut violently and it took everything i had to open my eye for the few brief seconds needed to take out the contact.After flushing my eye and finally relieving some of the pain, i am now left with one eye so red that it looks as if i dropped red food coloring directly into it.The bottle of clean care says clearly on the label: "important: failure to follow directions for use will result in burning and stinging." under the "directions" section, it says "tighten the cap and store lenses for at least 6 hours or overnight.Do not shake the case." i left my contacts in the solution for roughly 11 hours and was still unable to avoid the god awful pain.Because i have used this product before, i know very well to not put my contacts in my eyes until the recommended time has elapsed, and i definitely have not misused the product or failed to follow the directions.For the safety of consumers, this product needs to be taken off of the market immediately.The formula needs to be dramatically changed if this is going to be safe at all.

• Brand Name: CLEAR CARE
• Type of Device: CLEAR CARE
• Manufacturer (Section D): CIBA VISION
• MDR Report Key: 3727729
• MDR Text Key: 4323185
• Report Number: MW5035457
• 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: 03/31/2014

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: Lay User/Patient
• Device Expiration Date: 05/31/2014
• Device Lot Number: 20379
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2014
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 64