MAUDE Adverse Event Report: ALCON RESEARCH, LTD. CLEAR CARE EYE SOLUTION CASE; CASE, CONTACT LENS

Device Problem Insufficient Information (3190)

Patient Problems Purulent Discharge (1812); Red Eye(s) (2038); Burning Sensation (2146)

Event Date 01/01/2018

Event Type  No Answer Provided  

Event Description

Clear care, i fell asleep with my contacts in.I woke up in the middle of the night, and put my contacts in the clear care eye solution container as specified, with the proper amount of solution.When i woke up , i put my contacts in, and they immediately started burning.I took them out.I realized that they must not have sat in the contact container for the full six hours.This morning, one day later, my eyes are still red, watering, burning, and my right eye has begun secreting green mucus.I am very unhappy, clear care should make it clear that chemical burns can occur on your eye if contacts do not sit in the container long enough.Medication administered to or used by the patient: no; in my opinion, they do not provide adequate warnings on their package.(b)(6).

• Brand Name: CLEAR CARE EYE SOLUTION CASE
• Type of Device: CASE, CONTACT LENS
• Manufacturer (Section D): ALCON RESEARCH, LTD.
• MDR Report Key: 8227172
• MDR Text Key: 132568012
• Report Number: MW5082904
• Device Sequence Number: 0
• Product Code: LPN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1