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

Lot Number 10605170089005

Device Problems Use of Device Problem (1670); Material Split, Cut or Torn (4008)

Patient Problem Eye Infections (4466)

Event Type  Injury  

Event Description

This incident was reported by the patient, they contacted the manufacturer and alleged that the lenses have become damaged which resulted in an eye infection.Patient stated she was prescribed zylette.The healthcare provider stated the patient only contacted them about the lens damage but is being treated for an eye infection and feels it is unrelated to a device problem but related to patient misuse.They indicate the patient is overusing and overwearing the contact lenses, including sleeping with them.This event is being reported with an abundance of caution due to the indication of the eye infection of unknown severity and resolution.Should further information become available, a follow-up report will be submitted as appropriate.

Manufacturer Narrative

No device sample was returned for manufacturer analysis.Manufacturing record review found no issues or nonconformance's and no trends were identified.No device related root cause could be established.The relationship between the coopervision device and the incident is unconfirmed.Should additional information become available, coopervision will complete additional investigations and submit a follow-up report as appropriate.It is unknown if the reported infection occurred in the right (od), left (os), or both (ou) eyes.As patient uses a different device in each eye, please refer to manufacturer report cc522375/9614392-2023-00014 for the linked incident report.

Manufacturer Narrative

Device sample returned for analysis, received 05 june 2023 and analysis completed on 29 june 2023.Manufacturers incident report is updated to reflect the results of device analysis and investigations.Refer to the following fields for updated or corrected data: b4, b6, d9, g2, g3, g6, h2, h3, h6.Based on manufacturer analysis of the returned device(s) and investigation, no root cause could be established.The relationship between the cooper-vision device and the event is unconfirmed.Should additional information become available additional investigation will be completed and a follow-up submitted as appropriate.It is unknown if the reported infection occurred in the right (od), left (os), or both (ou) eyes.As patient uses a different device in each eye, please refer to manufacturer report (b)(4) 9614392-2023-00014-1 for the linked incident report.

• 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: 16861478
• MDR Text Key: 314481308
• Report Number: 9614392-2023-00013
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 10605170089005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: Female