MAUDE Adverse Event Report: ALCON LABORATORIES, INC. CLEAR CARE PLUS 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number 13NH6R

Device Problems Break (1069); Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2021

Event Type  malfunction  

Event Description

The lid of the lens case on a package of clear care plus hydrogen peroxide solution broke, making it impossible for me to close the case properly and use the case to clean my contact lenses.The part that broke was the top of the lens case itself.Fda safety report id# (b)(4).

• Brand Name: CLEAR CARE PLUS 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON LABORATORIES, INC.
• MDR Report Key: 11677898
• MDR Text Key: 246030076
• Report Number: MW5100811
• Device Sequence Number: 1
• Product Code: LPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2021
• Device Lot Number: 13NH6R
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1