CLEAR CARE PLUS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-20 for CLEAR CARE PLUS manufactured by Alcon Research, Llc.

Event Text Entries

[180780629] Picked up alcon clear eye care from store, looking for multi-purpose contact lens cleaner. Next morning i put in my lenses and had extreme burning sensation. Pain was about 9 of 10. I subsided after i removed lenses and washed my eyes with water. By afternoon discomfort grew substantially. I went to emergency room and spent 3 hours at (b)(6) in (b)(6). Staff never asked what lens solution i used probably because they thought it was saline as i did. In fact it was 3% hydrogen peroxide. This should never be available over the counter. It is insane that fda allowed this in the first place. Imagine a teenager picking this up? When i returned home i did notice several read boxes that were not very visible. The front of the package has no red box but it does have pictures of product with red caps. I returned to a drug store today to pick up saline solution. The products were comingled with other contact lens solutions. Because they were placed at the bottom of the shelf none of the warnings were visible.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093170
• MDR Report Key: 9739594
• Date Received: 2020-02-20
• Date of Report: 2020-02-18
• Date of Event: 2020-02-17
• Date Added to Maude: 2020-02-21
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: CLEAR CARE PLUS
• Generic Name: ACCESSORIES, SOFT LENS PRODUCTS
• Product Code: LPN
• Date Received: 2020-02-20
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ALCON RESEARCH, LLC

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-02-20
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-20