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

Lot Number 12288070086013

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Corneal Ulcer (1796); No Clinical Signs, Symptoms or Conditions (4582)

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.Note: as it is unknown which eye (os/od) , or if both eyes (ou) were involved, please refer to linked manufacturer report cc549016 9614392-2024-00004 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.

• 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: 18623190
• MDR Text Key: 334326959
• Report Number: 9614392-2024-00003
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

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: 12288070086013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• 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
• Patient Age: 37 YR
• Patient Sex: Female