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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC DAILIES AQUACOMFORT PLUS MULTIFOCAL LENS, CONTACT, (DISPOSABLE)

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ALCON RESEARCH, LLC DAILIES AQUACOMFORT PLUS MULTIFOCAL LENS, CONTACT, (DISPOSABLE) Back to Search Results
Catalog Number CBV92012961
Device Problem Material Split, Cut or Torn (4008)
Patient Problems Corneal Ulcer (1796); Irritation (1941)
Event Date 07/18/2020
Event Type  Injury  
Manufacturer Narrative
The complaint sample has been returned for evaluation. 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 website on (b)(6) 2020, consumer stated that on (b)(6) 2020, she experienced irritation while wearing the lens, when removed the lens she found it torn. The consumer also experienced red eye. On (b)(6) 2020, consumer was diagnosed with corneal ulcer. Consumer was recommended to apply anti-bacterial and antibiotic eye drops 6 times per day and eye ointment to be applied once per day before going to sleep. Iv drip was also give. Consumer visited the doctor daily. On (b)(6) 2020 symptoms were resolved.
 
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Brand NameDAILIES AQUACOMFORT PLUS MULTIFOCAL
Type of DeviceLENS, CONTACT, (DISPOSABLE)
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 Key10476628
MDR Text Key205366972
Report Number1065835-2020-00011
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K123994
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,Followup,Followup
Report Date 10/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBV92012961
Device Lot NumberA0581209
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/10/2019
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: 09/01/2020 Patient Sequence Number: 1
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