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

Lot Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Eye Infections (4466)

Event Type  Injury  

Event Description

This incident was received by via the online retailer, 1-800 contact, as reported to them by the patient and limited information provided.The patient alleges experiencing recurrent eye infections or symptoms resembling an eye infection.The patient has reported seeking medical attention and receiving an undisclosed medication.Good faith efforts have been made obtain more 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 unknown nature or severity of the alleged infection(s) with a lack of medical information, and potential for permanent injury.Should further information become available, a follow-up report will be submitted as appropriate.This incident involves both the right and left eyes, with the patient wearing different device model in each eye.Please refer to linked manufacturer report (b)(6) 9614392-2024-00011 for second associated incident report.

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.This incident involves both the right and left eyes, with the patient wearing different device model in each eye.Please refer to linked manufacturer report (b)(6) 9614392-2024-00011 for second associated 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: jose rodriguez ; 209 high point dr; victor, NY 14564 ; 5857569847
• MDR Report Key: 18846688
• MDR Text Key: 337006217
• Report Number: 9614392-2024-00012
• 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: Consumer,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• 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: 02/06/2024
• 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 Sex: Male