MAUDE Adverse Event Report: ALCON RESEARCH, LLC CLEAR CARE; ACCESSORIES, SOFT LENS PRODUCTS

Device Problems Improper or Incorrect Procedure or Method (2017); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2020

Event Type  Injury  

Event Description

Accidentally confused clear care solution with saline since it was right next to the other saline's and soaked my contacts in it in the normal case because the box did not explain that the case neutralizes the hydrogen peroxide.No where on the box does it say anything about it having to be neutralized and it doesn't state why you have to use a specific case.Had problems after switching from one product maker to another maker: yes.

• Brand Name: CLEAR CARE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 10295433
• MDR Text Key: 199736452
• Report Number: MW5095603
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/16/2020

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2020
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 56