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

Lot Number 12908070098515

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

Patient Problems Corneal Edema (1791); Corneal Ulcer (1796); Hypopyon (1913); Red Eye(s) (2038); Blurred Vision (2137); Burning Sensation (2146); Corneal Infiltrates (2231); Eye Pain (4467)

Event Date 08/18/2023

Event Type  Injury  

Manufacturer Narrative

(h3): no product has been made available for manufacturer analysis.Investigation of manufacturing and quality records identified no issues, non-conformances, or trends.The causal relationship between the coopervision device and the incident is unconfirmed.Should further information become available investigations will be completed as applicable and a follow-up report submitted as appropriate.

Event Description

This incident was initially received by the manufacturer as redness, eye pain, and/or burning sensation of the eye after device use.Further information received indicates the patient was seen on (b)(6) 2023 with symptoms of eye pain and redness.The patient presented with severe corneal infiltrate, hypopyon, limbal and bulbar injection, and moderate epithelial and stromal oedema and was diagnosed with a 1.8x1.8mm central corneal ulcer (abscess) in the right (os) eye.The patient was admitted to the hospital for five days and was treated with vancomycin and fortum (ceftazidime), ciloxan (ciprofloxacin) and tobradex (tobramycin and dexamethasone).Corneal cultures were taken and negative for bacteria, viruses, fungi, and amoebae.The incident resulted in a central corneal opacity and a permanent reduction in visual acuity.This event is being reported due to the indication of a central corneal ulcer with permanent impact on the patient's visual acuity.Should further information become available investigations will be completed as applicable and a follow-up report submitted as appropriate.

Manufacturer Narrative

Investigation of manufacturing and quality records identified no issues, non-conformances, or trends.The causal relationship between the coopervision device and the incident is unconfirmed.Should further information become available investigations will be completed as applicable and a follow-up report submitted as appropriate.Lens sample received and device analysis complete.Report updated to reflect additional manufacturer analysis and investigations.Please refer to the following fields for updated content: b6, d9, g6, h2, h3, h6.

• Brand Name: BIOFINITY SPHERE (COMFILCON A)
• Type of Device: BIOFINITY SPHERE (COMFILCON A)
• Manufacturer (Section D): COOPERVISION MANUFACTURING, LTD.; south point; hamble unit 2; southamptom, hampshire SO31 4RF; UK SO31 4RF
• Manufacturer (Section G): COOPERVISION MANUFACTURING, LTD.; south point; hamble unit 2; southamptom, hampshire SO31 4RF; UK SO31 4RF
• Manufacturer Contact: melissa torpey ; 209 high point drive; suite 1100; victor, NY 14564 ; 5857569874
• MDR Report Key: 18573295
• MDR Text Key: 333624136
• Report Number: 9614392-2024-00002
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P080011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 12908070098515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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; Hospitalization; Required Intervention; Disability
• Patient Age: 25 YR
• Patient Sex: Male