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

Lot Number 10608070156508

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Corneal Ulcer (1796); Eye Injury (1845); Foreign Body Sensation in Eye (1869); Red Eye(s) (2038)

Event Date 09/23/2023

Event Type  Injury  

Manufacturer Narrative

(see h3) 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 it is unknown if this incident involves both right and left eye and patient was wearing a different device in each eye.Please refer to linked manufacturer report (b)(6) 9614392-2023-00029 for second associated incident report.

Event Description

This incident was received by the healthcare professional and limited information has been made available.According to the details provided, the patient experienced what is described as corneal ulcer or corneal detachment.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 or unclear diagnosis with unknown nature or severity of the incident, lack of supporting medical information and unknown patient resolution.Should further information become available, a follow-up report will be submitted as appropriate.This it is unknown if this incident involves both right and left eye and patient was wearing a different device in each eye.Please refer to linked manufacturer report (b)(6) 9614392-2023-00029 for second associated incident report.

Manufacturer Narrative

Manufacturers investigation of the returned device and manufacturing records found no failures or nonconformances and no trends were identified.No root cause could be established, the relationship between the coopervision device and the incident is unconfirmed.Device sample returned for analysis, received 07 november 2023 and investigation completed 14 november 2023.This it is unknown if this incident involves both right and left eye and patient was wearing a different device in each eye.Please refer to linked manufacturer report (b)(4) 9614392-2023-00029-2 for second associated incident report.

Event Description

This incident was initially reported under 9614392-2023-00028 on 19 september 2023 as an alleged corneal ulcer without supporting information.New relevant information was received on 19 october 2023.The information provided states the patient sought medical attention (b)(6) 2023 due to a stuck lens in the left (os) eye.During the examination, bulbar injection, tarsal papillae, and epithelial staining were observed.No additional information was provided on the incident or injury and no formal diagnosis was provided.As part of the patient's treatment plan, the patient was prescribed a preservative free eyewash solution (dacudoses), antiseptic eye drops (vitabact), and sodium hyaluronate eye lubricant (vismed).There is no information provided on the initially reported injury of corneal ulcer or corneal detachment, the details of that alleged event remain unknown.Information provided indicates the patient was using a different device in each eye.While this new information indicates involvement of the left eye only, it is unknown which device was being worn in that eye.Please refer to linked manufacturer report (b)(6) 9614392-2023-00029-1 for second associated incident report.

Manufacturer Narrative

New relevant medical information received 19 october 2023.No product has been made available for manufacturer analysis.Lot number was provided for the device alleged to be involved in the incident.Based on investigation no root cause could be established.The relationship between the coopervision device and the incident is unconfirmed.Manufacturers incident report is updated to reflect new details and the results of device manufacturing records review.Refer to the following fields for updated or corrected data: a2, b4, b5, b6, d4, g2, g3, g6, h2, h4, h6, h10.This it is unknown if this incident involves both right and left eye and patient was wearing a different device in each eye.Please refer to linked manufacturer report (b)(6) 9614392-2023-00029-1 for second associated 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: 17904523
• MDR Text Key: 325305740
• Report Number: 9614392-2023-00028
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 10608070156508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2023
• 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: 57 YR
• Patient Sex: Female