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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON CLEAR CARE PLUS WITH HYDRAGLYDE MOISTURE MATRIX; CLEANING SOLUTION LENS
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ALCON CLEAR CARE PLUS WITH HYDRAGLYDE MOISTURE MATRIX; CLEANING SOLUTION LENS Back to Search Results
Lot Number H14123-1215
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dry Eye(s) (1814); Corneal Clouding/Hazing (1878)
Event Date 08/08/2017
Event Type  Injury  
Event Description
Switched from clear care contact cleaner to the clear care hydraglyde.Shortly after inserting my contacts that were cleaned in the new hydraglyde solution, my vision became hazy/smokey.I took the contacts out and cleaned them with saline solution thinking that the haziness was due to dryness.Once i put the contacts back in, they remained hazy.I also noticed a rainbow ring around lights.Once i had removed the contacts, my vision remains hazy.I did not experience any pain, only haziness and dryness.Dates of use: (b)(6) 2017.The problem did not stop after the person reduced the dose or stopped taking or using the product."did the problem return if the person started taking or using the product again: yes." reason for use: to clean contact lenses.
 
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Brand Name
CLEAR CARE PLUS WITH HYDRAGLYDE MOISTURE MATRIX
Type of Device
CLEANING SOLUTION LENS
Manufacturer (Section D)
ALCON
MDR Report Key6776745
MDR Text Key82371183
Report NumberMW5071449
Device Sequence Number1
Product Code LPN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date01/31/2019
Device Lot NumberH14123-1215
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age30 YR
Patient Weight55
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