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

Lot Number 18376000076009

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

Patient Problem Keratitis (1944)

Event Type  Injury  

Manufacturer Narrative

No device sample was returned for manufacturer analysis.A lot number was provided for the device alleged to be involved in the incident.Lot history, device history, sterilization records, and trend reporting were reviewed.No issues or nonconformance's were found and no trends were identified.No 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.

Event Description

This incident was reported by the distributor, grandvision, and limited information has been made available.It is reported that the patient experienced keratitis, or corneal inflammation, in the right eye after wearing contact lenses.The distributor reports that while the patient sought medical treatment, no hospitalization was required and the incident did not result in any permanent injury.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, unconfirmed diagnosis, and unknown patient resolution.Should further information become available, a follow-up report will be submitted as appropriate.

• Brand Name: BIOFINITY ENERGYS (COMFILCON A)
• Type of Device: BIOFINITY ENERGYS (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: 16418665
• MDR Text Key: 309985660
• Report Number: 9614392-2023-00007
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 18376000076009
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2023
• 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