MAUDE Adverse Event Report: ALCON RESEARCH, LLC DAILIES TOTAL 1; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBV92004051

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

Patient Problem Corneal Ulcer (1796)

Event Date 10/16/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was not provided and the complaint sample was not made available for evaluation.The investigation consisted of a review of the complaint trend for category corneal ulcer infectious for delefilcon (dailies total 1) product.A product specific investigation was not performed as no lot number was available.No sample evaluation was completed as no product was returned.There were no adverse trends identified for complaint category corneal ulcer infectious for this product from (b)(6) 2017 to (b)(6) 2019.A root cause was not confirmed.The manufacturer internal reference number is: (b)(4).

Event Description

It was reported by an eye care professional on 05dec2019, that three consumers had come into office with corneal ulcers over the course of the past month.It was reported that none of the consumers were misusing the lenses in any way.Additional information has been requested but not yet received.

Manufacturer Narrative

H.3., h.6.: two sealed samples were inspected and found to meet specifications for package integrity, ph, osmolality, surface, edge, base curve and diameter.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.Per the sterilization effectiveness memo, due to the sterilization cycle used to produce the contact 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.In addition, two sealed samples that were returned by the consumer were inspected and found to meet manufacturing specifications.There was no capa required as a result of this investigation as a root cause was not identified.Trends and complaint investigations will continue to be monitored and action taken if warranted.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received on 19dec2019 via email stating that the event took place at (b)(6) 2019.It was reported that the consumer experienced a painful, watery, red eye, photophobia and swelling.It was also reported that the eye affected was only the right eye.The consumer sought medical attention on (b)(6) 2019 and was diagnosed with corneal infiltrate/ulcer.The consumer was prescribed with moxifloxacin every 30 minutes for first hour then every hour after, tapered to four times a day after three days.It was reported that the symptoms have resolved.

Manufacturer Narrative

H.6.: patient code 3191- photosensitivity.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

• Brand Name: DAILIES TOTAL 1
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): ALCON RESEARCH, LLC; 11440 johns creek parkway; duluth GA 30097
• MDR Report Key: 9529234
• MDR Text Key: 175222967
• Report Number: 1065835-2019-00021
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K113168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: CBV92004051
• Device Lot Number: A5022716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR