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

Lot Number 12836000153018

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

Patient Problems Corneal Ulcer (1796); Acanthameba Keratitis (1945); Red Eye(s) (2038); Blurred Vision (2137); Eye Pain (4467)

Event Date 11/20/2023

Event Type  Injury  

Event Description

Information received from the contact lens prescribing optician, as provided by the patient.The optician recorded details based on the patient's descriptions as the patient was not seen or treated at this location at the onset of the incident.It was reported the patient experienced poor visual acuity, eye pain, and photosensitivity in the right (od) eye, and sought medical treatment where they were diagnosed with bacterial keratitis.Per the patient, the treating ophthalmologist noted that due to the bacterial infection, the patient developed a "corneal hole".Professional medical input from the manufacturers review is that this is a corneal ulcer.The optician notes at follow-up that while some symptoms remain, this has since healed without any permanent damage.Treatment included three different unidentified eye drops at 15-minute intervals until empty, and an unspecified antibiotic and eye ointment to be used daily.As of the date of the report the incident is unresolved and patient still has symptoms of temporarily decreased vision and photosensitivity.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 with an abundance of caution due to the alleged diagnosis of bacterial keratitis with a lack of medical information, unconfirmed diagnosis, and unknown patient resolution.Should further information become available, a follow-up report will be submitted as appropriate.

Manufacturer Narrative

No product has been made available for manufacturer analysis and no lot number provided for manufacturer investigation.Given the lack of available device information, the manufacturer is unable to complete further investigations at this time and no root cause can be established.The relationship between the coopervision device and the event is unconfirmed.Should further information become available, the manufacturer will complete further investigations as appropriate and submit a follow-up report as applicable.

Manufacturer Narrative

Device sample returned for analysis, received 1 january 2024 and analysis completed on 02 january 2024.Manufacturers incident report is updated to reflect the results of device analysis and investigations.Based on manufacturer analysis of the returned device(s) and investigation, no root cause could be established.The relationship between the coopervision device and the event is unconfirmed.Should additional information become available additional investigation will be completed and a follow-up 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: jose rodriguez ; 209 high point dr; victor, NY 14564 ; 5857569847
• MDR Report Key: 18360357
• MDR Text Key: 330933616
• Report Number: 9614392-2023-00036
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P080011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 12836000153018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2022
• 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: 54 YR
• Patient Sex: Female