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 Problems Corneal Ulcer (1796); Erythema (1840); Pain (1994); Blurred Vision (2137)

Event Date 10/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complaint sample has not returned for evaluation; the lot number is unknown.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

It was reported on 19dec2019 via email that a consumer experienced a blurry, painful, red and photophobic right eye on (b)(6) 2019.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 tobramycin and dexamethasone ophthalmic suspension every 30 minutes for four hours then every four hours thereafter, the duration of the treatment was not indicated.It was reported that the symptoms have resolved.

Manufacturer Narrative

H.3., h.6.: no sample received at time of investigation.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.See the review activities summary field and operational investigation summary field for additional details.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 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 nonconformances 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).

• 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: 9563505
• MDR Text Key: 175227584
• Report Number: 1065835-2020-00002
• 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
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: CBV92004051
• Device Lot Number: A5062751
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR