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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LLC. DAILIES AQUA COMFORT PLUS LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Device Problems Break (1069); Product Quality Problem (1506)
Patient Problems Erythema (1840); Pain (1994); Burning Sensation (2146); Discomfort (2330)
Event Date 09/20/2020
Event Type  malfunction  
Event Description
Damage to eye, discomfort; hello, i use the dailies aqua comfort plus contacts. I bought out a new prescription last year. Almost every contact breaks, i have experienced eye discomfort, redness, and even burning. The contacts break as they are put into eye, which causes immense pain. I reached out the company over two weeks ago. To this date, no follow up was made to contact me and investigate this situation. I'm happy to provide more information. Thank you, (b)(6). Fda safety report id # (b)(4).
 
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Brand NameDAILIES AQUA COMFORT PLUS
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
ALCON RESEARCH, LLC.
MDR Report Key12370269
MDR Text Key268471299
Report NumberMW5103505
Device Sequence Number1
Product Code LPL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2021
Is this an Adverse Event Report? No
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: 08/25/2021 Patient Sequence Number: 1
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