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

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Red Eye(s) (2038); Visual Impairment (2138); Burning Sensation (2146)

Event Date 01/01/2016

Event Type  Other  

Event Description

Description: after using alcon clear care contact solution to clean my lenses, i experienced an intense burning pain in my eye upon putting the contact in.After well over 24 hours, i am still experiencing burning, redness, and an inability to fully open my eye.Medication administered to or used by the pt: no.Outcome: i still cannot see out of my eye correctly and am still experiencing burning.Where did the error occur: pt's home.When and how was error discovered: the error was discovered when my eyes began burning.(b)(6).

• Brand Name: ALCON CLEAR CARE CONTACT SOLUTION
• Type of Device: ALCON CLEAR CARE CONTACT SOLUTION
• Manufacturer (Section D): ALCON LABORATORIES, INC.
• MDR Report Key: 5728690
• MDR Text Key: 47595328
• Report Number: MW5062876
• Device Sequence Number: 1
• Product Code: LPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 04/16/2016

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: 06/14/2016
• Type of Device Usage: N
• Patient Sequence Number: 1