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

Lot Number 11319070404008

Device Problem Insufficient Information (3190)

Patient Problems Red Eye(s) (2038); Eye Infections (4466)

Event Type  Injury  

Event Description

This incident was reported by the healthcare professional, and limited information has been made available.According to the details provided, the patient experienced redness immediately after inserting the contact lenses.The patient sought medical attention at a hospital and received an unspecified treatment.Subsequently, it was reported that the patient developed an eye infection of unknown nature, severity, treatment, or resolution.The reporting optician states the patient has indicated that the reported infection is linked to a bacterium the user picked up while horse-riding, however, the contact lens cannot be definitively ruled out as a causal or contributory factor.As of the date of this report additional information is unknown.This event is being reported with an abundance of caution due to the alleged infection 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.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), 9614392-2024-00005 for associated incident report.

Manufacturer Narrative

No product has been made available for manufacturer analysis.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.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), 9614392-2024-00005 for second associated incident report.

• 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: jose rodriguez ; 209 high point dr; victor, NY 14564 ; 5857569847
• MDR Report Key: 18614821
• MDR Text Key: 334215136
• Report Number: 9614392-2024-00006
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 11319070404008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• 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
• Patient Sex: Female