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

Lot Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Corneal Ulcer (1796)

Event Date 01/28/2024

Event Type  Injury  

Manufacturer Narrative

No product has been made available for manufacturer analysis and no lot number provided for manufacturer device related investigation.No reporter detail provided for incident follow-up/investigation.Given the lack of available 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.

Event Description

This incident was reported by the patient to the us fda authority via medwatch (mw5148050), and forwarded by the authority to the manufacturer; limited information has been made available.According to the details provided, the patient alleges experiencing a corneal ulcer.The patient has requested confidentiality and has not provided any contact details.Due to the lack of information and confidentiality request, the manufacturer us unable to follow-up for additional details.As of the date of this report, additional information is unknown.This event is being reported in an abundance of caution due to the allegation of corneal ulcer of unknown size, location, severity, treatment, or patient resolution, as corneal ulcer can result in permanent injury and/or require medication or medical intervention to prevent or preclude permanent injury.Should further information become available, a follow-up report will be submitted as appropriate.

• Brand Name: BIOFINITY SPHERE (COMFILCON A)
• Type of Device: BIOFINITY SPHERE (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: 18953947
• MDR Text Key: 338306399
• Report Number: 9614392-2024-00016
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: P080011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• 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: 02/21/2024
• 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