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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LABORATORIES, INC. CLEAR CARE
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ALCON LABORATORIES, INC. CLEAR CARE Back to Search Results
Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problems Pain (1994); Burning Sensation (2146)
Event Date 01/01/2016
Event Type  Other  
Event Description
Description: i accidentally reached for the clear hydrogen peroxide lens cleaner instead of my regular saline solution rinse.I even looked at the bottle thinking i was making sure it was the correct solution.Being nearsighted, i could barely make out the word, but thought i read clear solution and thought i had the correct bottle.I rinsed my lens and had it nice and wet for insertions.I could not believe the pain.What is worse, my eye clamped shut and i could not open it to remove the lens.I had to pry my eye open and splash it with water before i could even open my eye enough for removal.It burned all day.This is the second day and my vision in that eye is significantly worse.The bottle should be an entirely different shape.It is identical to my saline solution bottle.I never even realized the lid was red.Outcome: probably, hopefully temporary.I need to go to eye doctor.Where did the event occur: patient's home.When and how error discovered: severe burning.Very severe.Probably, hopefully temporary.I need to go to eye doctor.Patient counseling provided: unk.Reporter's recommendations: completely different bottle design.Screw-top lid.People with vision loss use this product.The bottle should not be identical to saline solution.(b)(4).
 
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Brand Name
CLEAR CARE
Type of Device
CLEAR CARE
Manufacturer (Section D)
ALCON LABORATORIES, INC.
MDR Report Key5913394
MDR Text Key53667665
Report NumberMW5064426
Device Sequence Number0
Product Code LPN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 06/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2016
Device Operator No Information
Type of Device Usage N
Patient Sequence Number1
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