MAUDE Adverse Event Report: ALCON CLEAR AND CLEAR

Device Problem Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 01/01/2016

Event Type  No Answer Provided  

Event Description

Hi! i have been reading about clear and clear eye solution and found this email to report an incident.Yesterday (christmas) i was at my mother's and even with the red top which i did notice i put the solution into one of my eyes.Now when i think back red does catch your attention but it is eye saline solution, and i have been putting this in my eyes for years.I am (b)(6) and been wearing contacts half my life.I agree with articles saying there needs to be a safety cap that only works with the eye case.This ruined our christmas and i'm still in pain 24 hours later, after reading all of the things online considering going to the hospital.Medication not administered to or used by the patient.Patient counseling provided is unknown.Relevant materials not provided.(b)(4).

• Brand Name: CLEAR AND CLEAR
• Type of Device: CLEAR AND CLEAR
• Manufacturer (Section D): ALCON
• MDR Report Key: 6331534
• MDR Text Key: 67608215
• Report Number: MW5067896
• Device Sequence Number: 1
• Product Code: LPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1