MAUDE Adverse Event Report: ALCON LABORATORIES, INC. HYDRAGLYDE CLEAR CARE PLUS; ACCESSORIES, SOFT LENS PRODUCTS

Device Problems Device Markings/Labelling Problem (2911); Inadequate Instructions for Non-Healthcare Professional (2956); Patient Device Interaction Problem (4001)

Patient Problems Burning Sensation (2146); Eye Pain (4467)

Event Date 08/11/2022

Event Type  Injury  

Event Description

Last night i put clear care hydraglyde in my contact case and placed my contacts in them.This morning i put my contact in and an intense burning and stinging pain happened instantly and i could not open my eye to remove the contact.I was finally able to remove it.When i read the bottle it stated that it was a hydrogen peroxide solution and could only be used with the appropriate contact case included.The packaging on the contact solution does not say warning, it just says "important".I have used contact solution for over 4 years and i bought this solution from the front counter of the occultist.Nobody explained it and there was no warning.I did not think i needed to read instructions because like i said i have used contact solution for over 4 years.There needs to be better warnings on this product mainly after researching it and seeing how many incidents like this have occurred with the same product.

• Brand Name: HYDRAGLYDE CLEAR CARE PLUS
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON LABORATORIES, INC.
• MDR Report Key: 15224364
• MDR Text Key: 297958359
• Report Number: MW5111468
• 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: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: PRENATALS
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White