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

Lot Number UNKNOWN

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

Patient Problems Eye Injury (1845); Visual Impairment (2138)

Event Date 04/01/2021

Event Type  Injury  

Event Description

This incident was reported by the patient's attorney, limited information has been made available.The patient's attorney alleges that coopervision contacts burned a macular hole in the patient's right eye after 30 minutes of use, causing some level or permanent vision loss.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 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

New relevant medical information received 28 february 2024.No root cause could be established.The relationship between the coopervision device and the incident is unconfirmed.Manufacturers incident report is updated to reflect new details and the results of device manufacturing records review.As both right and left eye were involved and patient was wearing a different device model in each eye, please refer to linked manufacturer report cc507371 9614392-2022-00024 for second associated device.

Event Description

This incident was initially reported under 9614392-2022-00023 on 13 october 2022 as an infectious corneal ulcer with allegation of ongoing medical intervention, while awaiting a corneal transplant due to injuries sustained.Additional information was received on 28 february 2024 the results of the corneal cultures, which indicated the growth of pseudomonas.However, no further information regarding treatments was provided.Should further information become available, a follow-up report will be submitted as appropriate.As both right and left eye were involved and patient was wearing a different device model in each eye, please refer to linked manufacturer report cc507371 9614392-2022-00024 for second associated device.

• 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: 15544813
• MDR Text Key: 301200236
• Report Number: 9614392-2022-00023
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Other
• Patient Age: 36 YR
• Patient Sex: Male