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

Device Problem Insufficient Information (3190)

Patient Problems Red Eye(s) (2038); Burning Sensation (2146)

Event Type  Other  

Event Description

This is my first time getting contact lenses, and i used clear care eye as the solution, the eye exam doctor told me i should clean my contacts with it, which i did.This morning i was cleaning my contacts and i put it in my eye and my eye started burning and started getting watery and extremely red.I couldn't open my eye to take out my contact, i was laying on the ground screaming.I had finally taken out my contact and my eye continued to burn and still burning.(b)(6).

• Brand Name: CLEAR CARE
• Type of Device: CONTACT SOLUTION
• Manufacturer (Section D): ALCON LABORATORIES, INC.
• MDR Report Key: 5186976
• MDR Text Key: 29929305
• Report Number: MW5057416
• 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: 08/12/2015

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