MAUDE Adverse Event Report: ALCON CLEAN CARE PLUS; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number 284970F

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Burning Sensation (2146)

Event Date 09/01/2017

Event Type  Injury  

Event Description

I've had to switch to clean care plus after the peroxi-clear recall.About twice a week, after rinsing my contact with saline, my eye burns and turns red.It's painful.I quickly remove the lens.I soak in the same saline while i shower.I can put the lenses in after that.This is crazy! they shouldn't burn after rinsing.I use the saline (bio true) to flush my eye and to soak the lenses so i know it's not that.It's the clean care.I used it before and that's why i switched to the peroxi-clear.Why was the person using the product: to clean contacts.

• Brand Name: CLEAN CARE PLUS
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON
• MDR Report Key: 6845494
• MDR Text Key: 85134208
• Report Number: MW5071981
• 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: Other
• Type of Report: Initial
• Report Date: 09/01/2017

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: 03/31/2019
• Device Lot Number: 284970F
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR