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

Lot Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Red Eye(s) (2038); Corneal Infiltrates (2231); Excessive Tear Production (2235); Eye Pain (4467); Swelling/ Edema (4577)

Event Date 11/18/2023

Event Type  Injury  

Manufacturer Narrative

(h3): no product has been made available for manufacturer analysis and no lot number provided for manufacturer investigation.Given the lack of available device information, the manufacturer is unable to complete further investigations at this time and no root cause can be established.The relationship between the coopervision device and the event is unconfirmed.Should further information become available, the manufacturer will complete further investigations as appropriate and submit a follow-up report as applicable.

Event Description

This incident was reported by eye care practitioner to the manufacturer.It is reported that the patient experienced pain, redness, irritation, photophobia, foreign body sensation, epiphora and sought medical treatment on (b)(6) 2023.The eye care practitioner indicates the patient is currently wearing on an extended to continuous wear basis with around the clock wear for approximately one month duration prior to removal and replacement.Examination identified corneal infiltrate in the 6 o'clock region, about one millimeter in size, with associated epithelial staining, epithelial and stromal edema, bulbar injection and corneal scar in the left eye (os).The patient was instructed to temporarily cease lens use and was treated with vita-pos eye drops to be instilled 6 times a day.As symptoms worsened, the patient contacted ophthalmology emergency on the following day, (b)(6), 2023, at (b)(6) hospital.The patient was diagnosed with a corneal ulcer and received unspecified treatment.Further medical information or records for this visit have not been received by the manufacturer.The patient had a follow-up visit with the eye care practitioner on (b)(6), 2024, the incident has resolved and the patient was approved to return to contact lens wear but advised to decrease wear time to only a couple of hours a day and no extended wear use.The practitioner also intends to refit the patient to a daily disposable device.The patient had follow-up visit for an annual check-up with the eye care practitioner on (b)(6), 2024, visual acuity was back to normal in both eyes with an inactive scar at the site of the ulcer about 1mm in diameter.The patient is being fitted with a disposable contact lens.This event is being reported due to diagnosis of corneal ulcer with medical interventions and/or medication(s) prescribed to prevent or preclude a permanent injury to the eye structure or function.Should further information become available, a follow-up report will be submitted as appropriate.

• Brand Name: BIOFINITY MULTIFOCAL (COMFILCON A)
• Type of Device: BIOFINITY MULTIFOCAL (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: 18641501
• MDR Text Key: 334614537
• Report Number: 9614392-2024-00007
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: No
• 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; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female