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U.S. Department of Health and Human Services

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

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ABBOTT LABORATORIES, INC. CLEAR CARE; ACCESSORIES, SOFT LENS PRODUCTS Back to Search Results
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).
 
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Brand Name
CLEAR CARE
Type of Device
ACCESSORIES, SOFT LENS PRODUCTS
Manufacturer (Section D)
ABBOTT LABORATORIES, INC.
MDR Report Key10270099
MDR Text Key198874997
Report NumberMW5095501
Device Sequence Number1
Product Code LPN
Combination Product (y/n)N
Number of Events Reported1
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 Received07/13/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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