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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 CBV92004051
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Ulcer (1796); Pain (1994); Visual Impairment (2138); Discomfort (2330)
Event Date 06/22/2019
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: no consumer complaint samples were received at the time of investigation. During the final inspection -secondary packaging ((b)(4)) process step, quality personnel inspect all retain sample blisters for saline level in individual primary package. If a leaky blister is identified during inspection, a non-conformance is initiated. No non-conformances have been identified for the complaint lot. The investigation included a review of the complaint history/trend, manufacturing records, component nonconformance history, nonconformance history, in process sampling/control information, equipment logbook, sterilization, retain sample inspection and training deviations. There were no deviations that would contribute to the nature of the complaint. The lot met release criteria and is acceptable for continued distribution. No root cause was able to be identified based on the manufacturing conditions as all processes were reviewed and found to be within specifications. Due to the sterilization cycle used to produce dailies total 1 lenses, it can be concluded that any infection of the eye suffered by patients using lenses that have been terminally sterilized and are taken from an intact primary package cannot be the result of any organism originating from that package. There were no non-conformances identified related to sterilization of the complaint lot. In addition, the consumer did not indicate any leaking packages or that there was no saline in any package or any other seal related events, no sealing related defects were identified during any in process inspections of the complaint lot, nor during final inspection of the complaint lot. The manufacturer internal reference number is: (b)(4).
 
Event Description
It was reported on (b)(6) 2019 that a female consumer said she has ulcers in her eyes. Symptoms were continuing. New information received on 28jun2019 via a phone call from the consumer stated that she had a corneal ulcer develop in her right eye (od). She has seen her ecp and has been treated for corneal ulcer for 1 week. She did not know the name of drops used for treatment. She also reported that she thinks her vision has now changed in her od after being treated for a week. The consumer was hesitant to provide ecp information. New information received on 30jun2019 via email from the consumer stated that she woke up with right eye (od) irritation on (b)(6) 2019. The discomfort was so great and she went to an hcp who diagnosed her with "2 ulcers on cornea in each of my eyes with the right eye having the biggest ulcer. " she was prescribed with moxifloxacin 0. 5% one drop in each eye every hour for daytime, tobramycin 0. 3% gel for night time and instructed not to wear contact lenses. She went back to the hcp on (b)(6) 2019 and it was noted that the ulcers have been healing. She continued the medications for another two days and then was prescribed loteprednol etabonate 0. 38% 1 drop each eye three times a day to try to heal the scar from the ulcers. By the end of the week, she noticed that the vision in her right eye became much worse than before and her glasses were not sufficient for her right eye to see letters clearly on the computer. Her eye condition is being monitored by her doctor. She was still wearing glasses and does not want to wear contact lenses. 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
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152231
MDR Report Key8817010
MDR Text Key152027960
Report Number1065835-2019-00013
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 distributor,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2021
Device Catalogue NumberCBV92004051
Device Lot NumberA5054129
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/12/2018
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: 07/23/2019 Patient Sequence Number: 1
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