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

Lot Number 12907070409007

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

Patient Problems Acanthameba Keratitis (1945); Unspecified Eye / Vision Problem (4471)

Event Type  Injury  

Event Description

This incident was reported by the optician to the manufacturer.It was reported that the patient had an unspecified reaction after wearing contact lens and went to hospital.Eye care provider suspect that it could be acanthamoeba which occurred within two weeks of wearing the lens.Good faith efforts have been made to obtain further information without success.As of the date of this report, additional information is unknown.This event is being reported in an abundance of caution due to the lack of medical information, unconfirmed diagnosis, and unknown patient resolution.Should further information become available, a follow-up report will be submitted as appropriate.

Manufacturer Narrative

(h3):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.

• Brand Name: BIOFINITY SPHERE(COMFILCON A)
• Type of Device: BIOFINITY SPHERE(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: spandana mannepalli ; 209 highpoint drive; suite 100; victor, NY 14564 ; 5857569688
• MDR Report Key: 17666396
• MDR Text Key: 322468496
• Report Number: 9614392-2023-00024
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P080011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 12907070409007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2023
• 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