MAUDE Adverse Event Report: ALCON RESEARCH, LLC CLEAR CARE TRIPLE ACTION CONTACT LENS CLEANING DISINFECTING SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Red Eye(s) (2038); Increased Sensitivity (2065); Swelling (2091); Burning Sensation (2146)

Event Date 05/25/2019

Event Type  Injury  

Event Description

Product clear care contact lens solution i used the product to soak my contacts overnight.Neglected to read the warning about only using the storage device provided.This device i later found out has a peroxide "neutralizer" attached to it.Because the device was difficult to use i instead put my contacts and the clear care solution in my regular flat contact lens storage case.When i put my first contact lens in my eye the next morning, it immediately burned severely.I frantically tried to remove the contact lens but couldn't keep my eye open long enough to do so.The burning was intense.It took about a min and a half to finally get it out, after which i flushed my eye under the bathroom shower.Without much relief, i decided to jump in the pool and open my eyes hoping to dilute the solution.Almost 12 hours later my eye is still swollen, red, and extremely sensitive.I'm afraid i may have either scratched my eyeball or something worse.I believe the warnings on the labeling of this product are insufficient considering the extreme effects of making this mistake.I will see my dr if the problem persists for a few days.

• Brand Name: CLEAR CARE TRIPLE ACTION CONTACT LENS CLEANING DISINFECTING SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 8655360
• MDR Text Key: 146667550
• Report Number: MW5087004
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): Y
• 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: 05/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 72