MAUDE Adverse Event Report: ALCON LABORATORIES, INC. CLEAR CARE HYDRAGLIDE WITH HYDROGEN PEROXIDE; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number H14931-0618

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems Corneal Scar (1793); Eye Burn (2523)

Event Date 07/19/2018

Event Type  Injury  

Event Description

I purchased alcon clear care hydraglide with hydrogen peroxide contact cleaner.The product has harsh chemicals that are dangerous to normal human eyes.The solutions is deceptively placed in the gentle saline solution section of the eye car aisle.This product is not gentle and if it comes into contact with the eye it can cause corneal burning and life long alterations scars to the cornea.This product should not be placed with contact solutions that are mostly saline.Instead, these products should be placed near the hydrogen peroxide because they are more of a cleaner.This placement can confuse the consumer and lead to dangerous side effects, severe burns and hospitalizations if used incorrectly.This product is not gentle and should not be in the gentle saline solution aisle.Following the accident the doctor measured an acid content almost 50% above the normal for a healthy functioning eye.Prolonged increase in the acid levels of the eye led to corneal scarring, burns and eye damage which is persistent two years later.

• Brand Name: CLEAR CARE HYDRAGLIDE WITH HYDROGEN PEROXIDE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON LABORATORIES, INC.
• MDR Report Key: 10361764
• MDR Text Key: 201765747
• Report Number: MW5095867
• 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: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2021
• Device Lot Number: H14931-0618
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 33 YR
• Patient Weight: 89