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

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problems Burning Sensation (2146); Discomfort (2330)

Event Date 01/01/2020

Event Type  No Answer Provided  

Event Description

Clear care contact cleaner mistaken for contact lens solution.I ordered "contact lens solution" on (b)(6) and got this.Put it directly in my eye.I am a busy mom of two kids, working from home while also homeschooling them right now.I have a master's degree in education and i am generally very observant and cautious about chemical use and medications.This bottle looked just like contact solution.Yes, there was a red box with information about burning from improper use, but this was not enough- i didn't see it until after it burned my eyes.Temporary harm/injury, it happened today.Put it in my eye.Horrible burning and discomfort.(b)(6).Access number: (b)(4).

• Brand Name: CLEAR CARE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ABBOTT LABORATORIES, INC.
• MDR Report Key: 10270099
• MDR Text Key: 198874997
• Report Number: MW5095501
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1