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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC CLEAR CARE; ACCESSORIES, SOFT LENS PRODUCTS

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ALCON RESEARCH, LLC CLEAR CARE; ACCESSORIES, SOFT LENS PRODUCTS Back to Search Results
Device Problems Improper or Incorrect Procedure or Method (2017); Inadequate Instructions for Non-Healthcare Professional (2956)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/15/2020
Event Type  Injury  
Event Description
Accidentally confused clear care solution with saline since it was right next to the other saline's and soaked my contacts in it in the normal case because the box did not explain that the case neutralizes the hydrogen peroxide.No where on the box does it say anything about it having to be neutralized and it doesn't state why you have to use a specific case.Had problems after switching from one product maker to another maker: yes.
 
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Brand Name
CLEAR CARE
Type of Device
ACCESSORIES, SOFT LENS PRODUCTS
Manufacturer (Section D)
ALCON RESEARCH, LLC
MDR Report Key10295433
MDR Text Key199736452
Report NumberMW5095603
Device Sequence Number1
Product Code LPN
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/17/2020
Patient Sequence Number1
Patient Age23 YR
Patient Weight56
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