MAUDE Adverse Event Report: ALCON LABORATORIES, INC. CLEAR CARE; CONTACT SOLUTION

Device Problem Insufficient Information (3190)

Patient Problem Eye Injury (1845)

Event Date 01/01/2015

Event Type  Other  

Event Description

I placed the clear care cleaning solution on a regular contact lens case without even knowing it was a special solution and placed one of my contact lens into my right eye.This caused severe eye burn.The label is not obvious at all and i read the label after i had the accident.Eye burn all day so far.When and how was error discovered: immediate eye burn and was not able to open my right eye for 10 mins.This product should be prescribed by a doctor or sold by health professionals (hp) and consumer should be warned before using it.(b)(6).

• Brand Name: CLEAR CARE
• Type of Device: CONTACT SOLUTION
• Manufacturer (Section D): ALCON LABORATORIES, INC.
• MDR Report Key: 5186975
• MDR Text Key: 29929477
• Report Number: MW5057415
• Device Sequence Number: 1
• Product Code: LPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/01/2015

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: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other