MAUDE Adverse Event Report: ALCON CLEAR CARE PLUS CLEANING AND DISINFECTING SOLUTION FOR CONTACT LENSES; ACCESSORIES, SOFT LENS PRODUCTS

Model Number CLEAR CARE PLUS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Eye Injury (1845); Pain (1994); Red Eye(s) (2038); Burning Sensation (2146)

Event Date 05/20/2019

Event Type  Injury  

Event Description

I am a new contact lenses wearer and i went to (b)(6) with my daughter to get more contact solution for my lenses.I grabbed a double pack because my daughter (b)(6) needed a bottle too.Apparently, the clear care plus disinfecting solution which looks identical and is placed amongst the saline solution on the same shelf is not the same as saline solution.I've never even heard of disinfecting solution.We get home and my daughter opens the box, throws it away and sticks one bottle in her room and the other in mine.Well, i used it as saline solution and never before in my life has my eye ever burned more.I started screaming, it was bright red and i couldn't get the contact out.My eye just wanted to slam shut.I finally, painfully dig it out and rinses my eye out with wetting drops i had next to me.My daughter whose (b)(6) birthday was that day, came running in and i told her what happened.She said the same thing had happened to her that morning before school.She didn't even tell me, but it's probably because she didn't want to wake me up, she just thought her contacts were bad and went and grabbed a new pair.We were just about to go out for her birthday family dinner to (b)(6) and i had just finished doing my makeup and everyone was waiting for me and i had just needed to put my contacts in so we could go.I put my contact in and nearly burned my eye off, was in pain, ruined my makeup and still made everyone late.The entire birthday dinner was ruined and everyone kept asking me what was wrong with my eye.It was red and watery and a lot smaller than my left eye.My eye hurts terribly still the next day and is red and smaller than the other eye which thankfully you can only put in one contact at a time or they would both be feeling burned right now.This product is dangerous and is placed amongst the other saline solutions.It even has the same shape as the saline solution bottles.I thought the red cap was just part of their packaging design.It's too upsetting to know a product that feels like acid in your eye is allowed to be on the shelves.My god, i have little children as well.I didn't know there even existed such a thing.(b)(4).Retailer: (b)(6).Ref mw5087268.

• Brand Name: CLEAR CARE PLUS CLEANING AND DISINFECTING SOLUTION FOR CONTACT LENSES
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON
• MDR Report Key: 8687864
• MDR Text Key: 147854268
• Report Number: MW5087265
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• 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: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CLEAR CARE PLUS
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR