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

Lot Number 11317170145514

Device Problem Use of Device Problem (1670)

Patient Problems Corneal Ulcer (1796); Fungal Infection (2419)

Event Type  Injury  

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.It is unknown if this incident involves both right and left eye.As the patient uses a different device model in each eye, it cannot be confirmed if both devices were involved in the incident.Please refer to linked manufacturer report cc549465 9614392-2024-00008 for second associated incident report.

Event Description

This incident was initially reported by the patient, who alleged a fungal infection.Additional information was provided by the treating physician, indicating that the patient was treated for a corneal ulcer believed to have been caused by contact lens misuse and noncompliance.The treating physician indicates that the incident has fully resolved, however, as of the date of this report additional information is unknown on the location, severity, or treatments provided.This event is being reported due to the diagnosis of a corneal ulcer of unknown location, severity, or treatment; it is unknown if medications or medical intervention were required to prevent or preclude a permanent injury.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.As the patient uses a different device model in each eye, it cannot be confirmed if both devices were involved in the incident.Please refer to linked manufacturer report cc549465 9614392-2024-00008 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: 18768150
• MDR Text Key: 336118333
• Report Number: 9614392-2024-00009
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 11317170145514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: 68 YR
• Patient Sex: Female