MAUDE Adverse Event Report: ALCON CLEAR CARE; CONTACT LENSE SOLUTION

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Incontinence (1928); Pain (1994)

Event Date 01/01/2016

Event Type  Other  

Event Description

Woman just called to report she put clear care directly in her eye without using the neutralizing case.This occurred 2 hours ago and she is still in severe pain.She stated she had once used this product six months ago.She usually just uses saline but since her contacts were more dirty than usual she decided to use this product.She knew it had to be "neutralized" but didn't realize it had to be in a special case.She let her contacts sit for six hours in a regular lens case.She put one in her eye and immediately felt the worst pain in her life.She said the pain was so severe it actually caused her to urinate herself.Her whole day has been interrupted because of this.She is also very upset because her teenage daughter is a brand new contact lens wearer and she could have easily used this product as regular lens solution.Medication administered to or used by the pt: no.(b)(4).

• Brand Name: CLEAR CARE
• Type of Device: CONTACT LENSE SOLUTION
• Manufacturer (Section D): ALCON
• MDR Report Key: 6102275
• MDR Text Key: 60083185
• Report Number: MW5066028
• 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: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1