MAUDE Adverse Event Report: ALCON CLEAR CARE

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

Patient Problem Pain (1994)

Event Type  Other  

Event Description

I purchased clear care for the first time at (b)(6).Clear care is a solution for contact lenses.It was sold adjacent to other lens solutions in the store and i assumed it was the kind of solution i could put into lens case at night, then put lenses in my eyes this morning.But when i put the lenses in my eyes they stung like crazy.I read the cover of the box and thought i was using the product correctly.I went online to find out if others have had problems with clear care and discovered that others have used the product incorrectly.Evidently, this solution is not supposed to be put in eyes because it has a chemical that is dangerous in eyes.I still don't understand the purpose of clear care, but will need to throw it away and buy another product.I believe the labeling on the box was very misleading.My eyes are still uncomfortable, but i do not think it has causes serious damage.(b)(6).

• Brand Name: CLEAR CARE
• Type of Device: CLEAR CARE
• Manufacturer (Section D): ALCON
• MDR Report Key: 5454996
• MDR Text Key: 38864276
• Report Number: MW5060418
• Device Sequence Number: 1
• Product Code: LPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1