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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON, A NOVARTIS COMPANY CLEAR CARE WITH HYDROGEN PEROXIDE
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ALCON, A NOVARTIS COMPANY CLEAR CARE WITH HYDROGEN PEROXIDE Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Visual Impairment (2138); Eye Burn (2523)
Event Date 06/01/2016
Event Type  Injury  
Event Description
I use a product called clear care with hydrogen peroxide.I am very familiar with it and would never directly put in my eye.I purchased the double pack that is sold in stores that includes only one case for your contacts and the necessary neutralizations.I used the same case for both bottles of solution provided and i think the solution gradually stopped neutralizing in the 8 hour period it is supposed to.While the contacts don't hurt when i put them in my eyes, my vision to cloud.On (b)(6), i woke up in excruciating pain and discovered i had corneal burns from chemicals on both of my eyes.This was a surprise for me because i didn't experience pain when i put the contacts in to indicate the solution had not been neutralized.I think it was a slow and steady burn.The cause: i think the case provided is not sufficient to neutralize both bottles of peroxide provided.If the company provides two bottles, they should also provide two cases.
 
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Brand Name
CLEAR CARE WITH HYDROGEN PEROXIDE
Type of Device
CLEAR CARE WITH HYDROGEN PEROXIDE
Manufacturer (Section D)
ALCON, A NOVARTIS COMPANY
MDR Report Key6618178
MDR Text Key76951707
Report NumberMW5070190
Device Sequence Number1
Product Code LPN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age30 YR
Patient Weight59
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