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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 Material Deformation (2976)
Patient Problems Eye Injury (1845); Ulcer (2274); Discomfort (2330)
Event Date 10/21/2020
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
As initially reported by a female consumer via telephone on (b)(6) 2020 states in the past consumer found a folded lens after opening the blister. The consumer experienced discomfort and irritation when wearing the lens. Upon visiting a doctor the consumer was diagnosed with ulcer. Anti-inflammatory and anti-bacterial eye drops were prescribed and contact lens wear was discontinued for unknown period. Upon follow-up visit, symptoms recovered. Additional info has been requested but not yet available.
 
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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
8175514979
MDR Report Key10728266
MDR Text Key212792240
Report Number1065835-2020-00013
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K113168
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2020
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/23/2020 Patient Sequence Number: 1
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