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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LTD. CLEAR CARE 3% HYDROGEN PEROXIDE TRIPLE ACTION CONTACT CLEANING SOLUTION 355 ML; ACCESSORIES, SOFT LENS PRODUCTS

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ALCON RESEARCH, LTD. CLEAR CARE 3% HYDROGEN PEROXIDE TRIPLE ACTION CONTACT CLEANING SOLUTION 355 ML; ACCESSORIES, SOFT LENS PRODUCTS Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Erythema (1840); Swelling (2091); Caustic/Chemical Burns (2549); Fluid Discharge (2686)
Event Date 01/01/2018
Event Type  No Answer Provided  
Event Description
These happened as a result of the error.Visit to clinic/doctor; visit to an emergency room, more medicine to reduce or relieve the possible bad effects of the error.Other explanation: other outcomes - pending eye dr visit and further testing.Chemical burn to eye.I was wearing contacts and was at my sister's house and reached for what i thought was contact solution (same color bottle as contact solution).I am a health care professional and made this mistake.This chemical should not be in the same size, shape and color as regular contact solution.The only marking is a red cap.Not sufficient enough.This is a huge safety hazard.Headed to optometrist tomorrow, emergency clinic.Eye is severely swollen, draining and red.Visit to clinic/doctor.Visit to an emergency room.More medicine to reduce or relieve the possible bad effects of the error.Other explanation: other outcomes - pending eye dr.Visit and further testing.(b)(6), access number: (b)(4).
 
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Brand Name
CLEAR CARE 3% HYDROGEN PEROXIDE TRIPLE ACTION CONTACT CLEANING SOLUTION 355 ML
Type of Device
ACCESSORIES, SOFT LENS PRODUCTS
Manufacturer (Section D)
ALCON RESEARCH, LTD.
MDR Report Key8231305
MDR Text Key133190225
Report NumberMW5082961
Device Sequence Number1
Product Code LPN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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