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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 CBV92024182
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Burning Sensation (2146); Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
Upon initial receipt, the lot number was unknown. Refer to 2018-93173-01 for lot number asku. This is the second of two reports for the same patient involving two lot numbers of the same product for the samples received on 30may2019. It is unknown which lot number contributed to the event. Refer to 2018-93173-02 for the reported lot number a0560271. Four lenses in sealed blisters were received on 30-may-2019 at the investigation site. All four sealed blisters received were visually inspected. Two of the samples received were tested further. Samples 1 and 2, received sealed, were found to meet manufacturing specifications for package integrity, ph, and osmolality parameters, surface, edge, as well as, base curve and diameter parameters. A retain sample of ten blisters for the complaint lot was visually inspected for foil, shell, saline, and seal quality defects. No defects were identified during the retain sample inspection. The investigation included a review of the complaint history/trend, manufacturing records, component nonconformance history, nonconformance history, in process sampling/control information, equipment logbook, filling/packaging, 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. Per the sterilization effectiveness memo, due to the sterilization cycle used to produce nelfilcon a 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 was no capa required as a result of this investigation. Trends and complaint investigations will continue to be monitored and action taken if warranted. The manufacturer internal reference number is: (b)(4).
 
Event Description
It was reported by an optician on (b)(6) 2018 that the consumer felt discomfort and burning sensation upon introduction of contact lens samples to the right eye (od). The consumer continued with the contact lenses in the eye until the end of the day. The pain sensation did not resolve, so the consumer went to the ophthalmologist who identified a "lesion in the eye like a burning". Contact lens usage was suspended for 15 days. At the time of the initial report, the lot number and symptom resolution were unknown. Additional information has been requested but not yet received.
 
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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
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152231
MDR Report Key8732275
MDR Text Key149147028
Report Number1065835-2019-00011
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K123994
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBV92024182
Device Lot NumberA0539751
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/30/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/25/2019 Patient Sequence Number: 1
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