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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLERIO VISION AQUASOFT CONTACTS LENSES, SOFT CONTACT, DAILY WEAR

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CLERIO VISION AQUASOFT CONTACTS LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Hypersensitivity/Allergic reaction (1907); Burning Sensation (2146); Chemical Exposure (2570)
Event Date 09/03/2020
Event Type  Injury  
Event Description
Chemical burn in eyes; began experiencing a severe burning sensation in both eyes, headaches, and extreme light sensitivity three weeks ago. The doctor prescribed allergy medication. The pain and burning continue. I was unaware the source of the pain at first. Identified the cause of the pain was the contact lenses on (b)(6) 2020; 1800 contacts. Fda safety report id# (b)(4).
 
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Brand NameAQUASOFT CONTACTS
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
CLERIO VISION
Manufacturer (Section G)
VISCO VISION INC
MDR Report Key10513985
MDR Text Key206521049
Report NumberMW5096503
Device Sequence Number1
Product Code LPL
Reporter Country CodeUS
PMA/PMN Number
K160344
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/09/2020 Patient Sequence Number: 1
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