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

Lot Number UNKNOWN

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

Patient Problems Eye Injury (1845); Unspecified Eye / Vision Problem (4471); Insufficient Information (4580)

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)(4), 9614392-2023-00022 for second associated incident report.

Event Description

This incident was received via distributor, (b)(4), as reported to them by the end user, limited information has been made available.The patient reported unspecified corneal damage which they attributed to wearing contact lenses which the user indicates were larger in size (diameter) than they should have been.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 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.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), 9614392-2023-00022 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: 17509248
• MDR Text Key: 320890675
• Report Number: 9614392-2023-00023
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• 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: 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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