MAUDE Adverse Event Report: COOPERVISION MANUFACTURING, LTD BIOFINITY TORIC (COMFILCON A)

Lot Number 12798070042003

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

Patient Problems Corneal Ulcer (1796); Dry Eye(s) (1814); Hyperemia (1904); Visual Impairment (2138); Eye Pain (4467)

Event Date 09/13/2023

Event Type  Injury  

Manufacturer Narrative

(h3):no device sample was returned for manufacturer analysis.A lot number was provided for the device alleged to be involved in the incident.Lot history, device history, sterilization records, and trend reporting were reviewed.No issues or nonconformance's were found and no trends were identified.No root cause could be established.The relationship between the coopervision device and the incident is unconfirmed.Should additional information become available, coopervision will complete additional investigations and submit a follow-up report as appropriate.

Event Description

This incident was reported by the user to the local sales office who reported to the manufacturer.User information has not been provided to the manufacturer to date, contact details provided are for the local sales office.It was reported that the patient experienced dryness and irritation after instilling a new contact lens which developed into intense pain after continued wearing and remained after lens removal.The following day the user sought medical treatment and was diagnosed with corneal ulcer on the left eye (os).The user states that as of the date of report, they continue to experience poor or reduced vision.Good faith efforts have been made to obtain additional information without success, as of the date of this report additional information is unknown.This event is being reported in an abundance of caution due to unconfirmed diagnosis, lack of supporting medical information, and unknown patient outcome.Should further information become available, a follow-up report will be submitted as appropriate.

Manufacturer Narrative

(h3): additional medical information was received.No root cause could be established.The relationship between the coopervision device and the incident is unconfirmed.For updated data refer to the following sections: (a2), (a3), (b4), (b5), (g2), (g3), (g6), (h2), (h6), (h10).

Event Description

This incident was initially reported in an abundance of caution under [9614392-2023-00031] on (b)(6) 2023 as an alleged corneal ulcer without additional information.Additional medical information was received on 25 october 2023 from treating eye care professional.It was reported that the patient sought medical attention on (b)(6) 2023 for hyperemia of the left eye.Examination identified two paracentral corneal ulcers in the left eye (os), about 2mm next to the corneal apex, one in the 10 o'clock region and the other in 5 o'clock region, each about 0.5 millimeter in size.The patient was treated with unspecified medication (antibiotics and eye ointment) to be instilled hourly.The patient was seen for follow-up visit on (b)(6) 2023; no additional medical information was provided regarding this visit.Should further information become available, a follow-up report will be submitted as appropriate.

• Brand Name: BIOFINITY TORIC (COMFILCON A)
• Type of Device: BIOFINITY TORIC (COMFILCON A)
• Manufacturer (Section D): COOPERVISION MANUFACTURING, LTD; south point , hamble unit 2; southampton, hampshire SO31 4RF; UK SO31 4RF
• Manufacturer (Section G): COOPERVISION MANUFACTURING, LTD; south point , hamble unit 2; southampton, hampshire SO31 4RF; UK SO31 4RF
• Manufacturer Contact: spandana mannepalli ; 209 highpoint drive; suite 100; victor, NY 14564 ; 5857569688
• MDR Report Key: 17951611
• MDR Text Key: 325896622
• Report Number: 9614392-2023-00031
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P080011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 12798070042003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 10/25/2023
• Supplement Dates FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Sex: Male