MAUDE Adverse Event Report: CLEAR CARE; CONTACT LENS SOLUTION

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Nausea (1970); Pain (1994); Dizziness (2194); Reaction (2414)

Event Date 06/03/2014

Event Type  Injury  

Event Description

I followed all instructions exactly as printed by the manufacturer, and still burned my eyes on 2 occasions with clear care contact lens solution.After using the solution for a few months, i realize that 2 incidents is a very low percentage, but the burning i experienced was so intense that it affected my entire day on both occasions.The pain was so intense i couldn't see, experienced severe nausea and felt dizzy for the entire day.On all other days, this product worked fine, but after these 2 occasions and the intense pain, i will no longer use this product.It is my belief that injuries happen with this product even when all instructions are followed.Thank you very much.Dates of use: (b)(6) 2013 - (b)(6) 2014.Reason for use: recurring eye infections with soft contact lens wear.Manufacturer reported as: novartis.

• Brand Name: CLEAR CARE
• Type of Device: CONTACT LENS SOLUTION
• MDR Report Key: 3866756
• MDR Text Key: 4460734
• Report Number: MW5036507
• Device Sequence Number: 0
• 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: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 56