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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CIBA VISION CORPORATION CLEAR CARE
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CIBA VISION CORPORATION CLEAR CARE Back to Search Results
Device Problems Improper or Incorrect Procedure or Method (2017); Inadequate Instructions for Non-Healthcare Professional (2956)
Patient Problems Pain (1994); Loss of Vision (2139); Burning Sensation (2146); Chemical Exposure (2570)
Event Date 01/01/2012
Event Type  Other  
Event Description
Description: i purchased clear care solution at (b)(6) drugmart, assuming it was the regular multipurpose rinse solution.I read the bottle, but did not realize the importance of using the contact lens case - when the label stated that it should be used, i assumed that the command was simply a marketing technique.No side effects were stated in a noticeable way.I rinsed my contact lenses with clear care, and immediately after inserting them into my eyes experienced a horrible burning sensation.Even after flushing out my eyes, i could barely see and suffered eye pains all day - it was twenty excruciating minutes until i could stand to open my eyes at all.When and how was error discovered: the error was discovered when i experienced terrible pain in my eyes.Pt counseling provided: unk.Reporter's recommendations: i am horrified that a product as everyday as a bottle of contact solution can cause such pain, and after reading the many reports of injury from this product, am equally horrified that the problem of insufficient warnings has not been properly addressed even after several years.Either this product needs to be sold only with prescriptions, or the packaging needs to be much more noticeable with warnings.This is an extremely dangerous product and many people will not stop to read fine print on the bottle.(b)(4).
 
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Brand Name
CLEAR CARE
Type of Device
CLEAR CARE
Manufacturer (Section D)
CIBA VISION CORPORATION
MDR Report Key5187207
MDR Text Key29977562
Report NumberMW5057456
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 12/20/2012
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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