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

Lot Number 10589000080508

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Corneal Infiltrates (2231)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

The relationship between the coopervision device and the incident is unconfirmed.

Event Description

It was reported to the manufacturer in september 2020 that the patient experienced corneal infiltrates after using the device.The patient stated that there were two lenses contained in the same package which were simultaneously instilled in the eye.When the patient removed the lens, the second lens remained in the eye and was worn for four to five days continuously.The patient experienced unspecified symptoms and sought medical treatment where they were treated with ciprofloxacin drops, cyclopentolate drops, and an unspecified pain management medication for a corneal infiltrate.Good faith efforts have been made to obtain further information without success, additional information is unknown.Based on the information initially received, this event was reviewed and it was determined it did not meet the criteria of a reportable adverse incident.On 18 january 2021 additional information was received by the manufacturer indicating that the patient was left with an area of corneal opacity as a result of the incident and may require a corneal transplant.

Manufacturer Narrative

The manufacturer was recently made aware of a correction to the lot number initially provided regarding this incident.This report is being submitted with correct lot number, manufacturing date, and expiration date only, see fields d4 and h4.No further information has been received, no additional changes or updates have been made to the incident report form.

• Brand Name: BIOFINITY MULTIFOCAL (COMFILCON A)
• Type of Device: BIOFINITY MULTIFOCAL (COMFILCON A)
• Manufacturer (Section D): COOPERVISION MANUFACTURING, LTD.; south point; hamble unit 2; southamptom, hampshire SO31 4RF; UK SO31 4RF
• MDR Report Key: 11208384
• MDR Text Key: 228011926
• Report Number: 9614392-2021-00006
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• PMA/PMN Number: P080011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2024
• Device Lot Number: 10589000080508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention