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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC DAILIES TOTAL 1 LENSES, SOFT CONTACT, DAILY WEAR

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ALCON RESEARCH, LLC DAILIES TOTAL 1 LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBVUNK00017
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fungal Infection (2419)
Event Type  Injury  
Manufacturer Narrative
The complaint sample has not returned for evaluation; the lot number is unknown. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).
 
Event Description
This complaint is in reference to the alcon product dailies total 1. As initially reported by a healthcare professional, stated that the consumer experienced fungal infection in one eye. Symptoms resolution was unknown. Additional information has been requested but not yet received.
 
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Brand NameDAILIES TOTAL 1
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
ALCON RESEARCH, LLC
11440 johns creek parkway
duluth GA 30097
Manufacturer (Section G)
ALCON RESEARCH, LLC
11440 johns creek parkway
duluth GA 30097
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key12810949
MDR Text Key280755674
Report Number1065835-2021-00005
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113168
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBVUNK00017
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/15/2021 Patient Sequence Number: 1
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