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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEAR CARE
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CLEAR CARE Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Burn(s) (1757)
Event Date 01/01/2013
Event Type  Other  
Event Description
Description: i used clear care lens cleaning contact solution for the first time after running out of my typical solution.I was unaware the clear care solution is made with 3% hydrogen peroxide and used the solution to rinse my contact lens with clear care.Because i can't see without my contacts in, the meager red "important" label on the contact solution packaging escaped my notice.This happened to me.Practice site was at home, but the product was purchased over the counter at a drug store clear care liquid.When and how was error discovered: this was human error, but prompted by the product's insufficient labeling system.The error was discovered by applying the solution to a contact and placing it into my eye and immediately feeling excruciating pain and a burning sensation.It has been several hours since i was able to remove the contact from my swollen eye and i'm still in a great deal of pain and am considering going to an eye doctor to see if i've done serious damge to my eye (e.G., chemical burn as a result of applying hydrogen peroxide directly in my eye).Pt counseling provided: unk.Reporter's recommendations: better product labeling! the maker and distributor of the clear care product is incredibly irresponsible.The product should include a large "warning" sign on the front of the label (as opposed to its current "important" label).Additionally, it would help if the bottle shape was clearly distinguished from other common forms of contact solution that are benign when applied directly to eyes - for example, clear care could come in a pump bottle.The population of people using clear care's product are vision impaired.If we are unfamiliar with the product (as i was prior to misusing it), it is unreasonable to expect that the current labeling provides sufficient warning for a vision impaired consumer base that only has cause to use the product when they are preparing to put contacts in their eyes (in other words, we only use the product when we can't see).(b)(4).
 
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Brand Name
CLEAR CARE
Type of Device
CLEAR CARE
MDR Report Key5187219
MDR Text Key30019612
Report NumberMW5057464
Device Sequence Number1
Product Code LPN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 12/18/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Type of Device Usage N
Patient Sequence Number1
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