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

Catalog Number CBV92024182

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burning Sensation (2146); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Upon initial receipt, the lot number was unknown.Refer to (b)(4) for lot number asku.This is the first 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 (b)(4) for the reported lot number a0539751.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.(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.

• Brand Name: DAILIES AQUACOMFORT PLUS MULTIFOCAL
• Type of Device: LENS, 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 Key: 8732054
• MDR Text Key: 149148809
• Report Number: 1065835-2019-00010
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K123994
• Number of Events Reported: 1
• 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 Received: 06/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: CBV92024182
• Device Lot Number: A0560271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other