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

Lot Number 12252000117504

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

Patient Problems Corneal Ulcer (1796); Red Eye(s) (2038); Excessive Tear Production (2235); Eye Infections (4466); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

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.Note:as patient was using a different device/model in each eye and it is unknown which eye (os/od) , or if both eyes (ou) were involved, please refer to linked manufacturer report (b)(4) 9614392-2024-00015 for additional device incident report.

Event Description

This incident was reported by the end user's location of purchase to the manufacturer.It was reported that the patient experienced symptoms of swelling of the lower eyelid, runny eyes and redness and sought medical treatment.It was reported that the patient experienced a corneal ulcer and/or infection event and unspecified antibiotic medication(s) were prescribed.Good faith efforts have been made to obtain further information without success.As of the date of report, additional information is unknown.This event is being reported in an abundance of caution due to unconfirmed diagnosis, lack of medical information, and unknown patient outcome.Should additional information become available, coopervision will complete additional investigations and submit a follow-up report as appropriate.As patient was using a different device/model in each eye and it is unknown which eye (os/od) , or if both eyes (ou) were involved, please refer to linked manufacturer report (b)(4) 9614392-2024-00015 for additional device incident report.

• 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: 18895483
• MDR Text Key: 337563769
• Report Number: 9614392-2024-00014
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 12252000117504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: No
• 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; Required Intervention