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

Lot Number 12271000130013

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Unexpected Color (4055)

Patient Problems Corneal Ulcer (1796); Corneal Stromal Edema (1824); Corneal Infiltrates (2231); Ulcer (2274)

Event Date 12/03/2023

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.As it is unknown which eye (os/od) , or if both eyes (ou) were involved, please refer to linked manufacturer report (b)(4) 9614392-2024-00003 for associated incident report.

Event Description

This incident was reported by the optician to the manufacturer.It was reported that the patient sought medical treatment and was diagnosed with corneal ulcer and was treated with unspecified medication(s).Good faith efforts have been made to obtain further 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 diagnosis of corneal ulcer, with the lack of medical information and unknown patient resolution.Should further information become available, a follow-up report will be submitted as appropriate.

Manufacturer Narrative

Additional medical information was received.No root cause could be established.The relationship between the coopervision device and the incident is unconfirmed.

Event Description

This incident was initially reported under cc549016 9614392-2024-00004 on 01 february 2024 as a corneal ulcer and treated with unspecified medication(s).Additional medical information was received on 02 february 2024 from treating ophthalmologist.It was reported that the patient began experiencing symptoms on (b)(6) 2023 and sought medical treatment the following day.Examination identified ulceration of entire cornea and additional paracentral corneal ulcer in the 7 o'clock region of the left eye (os) with the onset of a stromal abscesses.The patient was treated with tobrex, ciloxan and vitamin a.The patient was seen for follow-up visits on (b)(6) 2023 and indicated improvement but has not returned for further care.No follow-up information available on the patient's current condition after the last visit on (b)(6) 2023.Should further information become available, a follow-up report will be submitted as appropriate.

Manufacturer Narrative

Device sample returned for analysis, received on 04 april 2024 and investigation completed on 08 april 2024.Manufacturing report updated to reflect device analysis and investigation results, refer to b6.The relationship between the coopervision device and the event could not be confirmed.For updated data refer to the following sections: (b4), (b6), (d9), (g2), (g3),(g6), (h2), (h3), (h6), (h11).

• 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: 18623285
• MDR Text Key: 334369721
• Report Number: 9614392-2024-00004
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P080011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 12271000130013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Female