MAUDE Adverse Event Report: ALCON LABORATORIES INC. / NOVARTIS PHARMACEUTICAL CORP. CLEAR CARE PLUS WITH HYDRAGLYDE; ACCESSORIES, SOFT LENS PRODUCTS

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems Headache (1880); Pain (1994); Burning Sensation (2146)

Event Date 12/05/2018

Event Type  Injury  

Event Description

I bought a twin pack of clear care plus (alcon a novartis company) and on the outside cardboard package on front, it did not say anything that you cannot put it in the eye directly or should use it somehow differently from other general lens solutions.I thought i bought normal lens solution and it was sold alongside with normal solutions.There are warning on the solution bottles which are inside the cardboard box (it is a twin pack sold in one cardboard box) but there are no warning on the front of cardboard package.Also the warnings on the bottles are not large enough for those who wear lenses.When i brought the cardboard box with clear care home, i took off my lenses into plastic lens container and then opened the box and put solution in my lens container.I did not realize there were special instructions on the bottle but there were no warning on the cardboard front.It is like you do not read instructions for use every time you buy soap or shampoo especially when you buy it in the soap/shampoo dept with many similar products and it looks like soap/shampoo.The following morning, i put one of the contacts in my left eye and experienced excruciating pain and burning.My eye clenched shut, delaying removal of the contact lens.The pain was unbelievable.I went to the dr and thankfully i did not have any permanent injuries (as dr said).I got eye burn due to hydrogen peroxide contained in this solution and i also got a severe headache.I am still recovering and i am not sure how the healing process will go.I wish nobody to have such experience.I think i will remember this pain forever.I do not want anybody else to suffer like me.This product should not be sold alongside with other lens solutions which cannot harm eyes.The product package and bottle shape should not also be similar to regular solutions and for sure there should be a large warning sign on the front of the product package prompting customers to be aware of eye burn.Dates of use: (b)(6) 2018.

• Brand Name: CLEAR CARE PLUS WITH HYDRAGLYDE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON LABORATORIES INC. / NOVARTIS PHARMACEUTICAL CORP.
• MDR Report Key: 8147016
• MDR Text Key: 130164879
• Report Number: MW5081979
• 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: 12/06/2018

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: No Information
• Device Expiration Date: 01/01/2020
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Weight: 70