MAUDE Adverse Event Report: ALCON RESEARCH, LLC CLEAR CARE CONTACT DISINFECTANT; ACCESSORIES, SOFT LENS PRODUCTS

Device Problems Labelling, Instructions for Use or Training Problem (1318); Use of Device Problem (1670)

Patient Problems Pain (1994); Eye Burn (2523)

Event Date 10/20/2020

Event Type  Injury  

Event Description

When putting my contacts in, i felt debris in my eye so i took the contact out and grabbed what i thought was "contact solution" from my daughter's room.I cleaned my contact with alcon clear care disinfectant solution.Immediately i experienced excruciating pain and fell to the floor.I struggled to pry my eye open and get the contact out.I began flushing my eye out with water.The pain has been unbelievable and it was difficult to make it through the day of teaching.I consulted a physician and it seems that my eye/cornea has been burned chemically.I am just outraged that this product that can cause injury to the eye, is permitted to be sold in packaging so similar to a product that has intended to go directly in the eye.Fda safety report id# (b)(4).

• Brand Name: CLEAR CARE CONTACT DISINFECTANT
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 10726065
• MDR Text Key: 213001753
• Report Number: MW5097417
• Device Sequence Number: 1
• Product Code: LPN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 77