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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON AQUA COMFORT PLUS DAILIES CONTACTS LENSES, SOFT CONTACT, DAILY WEAR

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ALCON AQUA COMFORT PLUS DAILIES CONTACTS LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Lot Number N0641516
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Irritation (1941); Discomfort (2330)
Event Date 03/30/2018
Event Type  Injury  
Event Description
About 5 mins after placing daily use contact in eye, contact began to feel irritated. After wiping my eye, the contact slid to the back of my eye. By blinking and moving my eye around, half of the contact came into view and i could retrieve it. My wife had to retrieve the other half from my eye. I experienced extreme discomfort. No permanent injury occurred to my knowledge. Product info: alcon aqua comfort plus dailies lot n0641516, exp 03/2021.
 
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Brand NameAQUA COMFORT PLUS DAILIES CONTACTS
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
ALCON
MDR Report Key7395301
MDR Text Key104431107
Report NumberMW5076282
Device Sequence Number1
Product Code LPL
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 03/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Lot NumberN0641516
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

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