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

Lot Number 10595070075506

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

Patient Problems Corneal Clouding/Hazing (1878); Eye Infections (4466)

Event Date 01/13/2024

Event Type  Injury  

Event Description

This incident was reported by the patient to the competent authority (uk mhra) via yellow card report reference (b)(4) | 7998067-aicxml and forwarded by the authority to the manufacturer, and limited information has been made available.According to the details provided, the patient has developed a microbial infection in the eye with corneal clouding/hazing, which they believe is related to a contaminated device.The patient reports that the event resulted in a minor injury, illness, or impairment and that medication was required.The patient also reports that remedial actions included contacts not being worn again, from the details provided it is unclear if this is in relation to the lenses involved in the event, or if the event resulted in a temporary or permanent discontinuation of lens use.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 unknown nature or severity of the incident 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.

Manufacturer Narrative

No device sample was returned for manufacturer analysis.Investigation of the provided lot number found no issues or non-conformances and no trends were identified.No root cause could be established.The relationship between the coopervision device and the event is unconfirmed.Should additional information become available, a follow-up report will be submitted as appropriated.

• Brand Name: BIOFINITY MULTIFOCAL (COMFILCON A)
• Type of Device: BIOFINITY MULTIFOCAL (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: 18928880
• MDR Text Key: 337984258
• Report Number: 9614392-2024-00013
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 10595070075506
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2024
• 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: 66 YR
• Patient Sex: Female