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

Lot Number R28799222

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

Patient Problems Keratitis (1944); Red Eye(s) (2038); Burning Sensation (2146)

Event Type  Injury  

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.

Event Description

This incident was reported by the patient's purchase location, grandvision to the manufacturer.It is reported that the patient experienced redness and a burning sensation in the right eye (od) after installing a new contact lens and sought medical treatment and is now instructed to discontinue lens use for four or five months.A physician's report was provided from the treating location, as provided by the patient's purchase location.The report indicates that patient was treated at (b)(6) hospital ophthalmology department for contact lens associated keratitis in the right eye and was prescribed gentax/ciloxan eye drops to be instilled hourly, and gentax as at night.Date of event not provided, but a follow-up visit on (b)(6) 2023 the physician reports an improvement in health and the patient is scheduled for follow-up again later in the week.Result of microbial scratch report is still pending.Doctor recommended a next follow-up visit at the end of week in (b)(6).Also reported that the patient was advised to not wear contact lens for four to five months.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 unknown patient resolution.Should further information become available, a follow-up report will be submitted as appropriate.

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.Device sample returned for analysis, received on 01 january 2024 and investigation completed on 02 january 2024.

• Brand Name: BIOFINITY TORIC MULTIFOCAL (COMFILCON A)
• Type of Device: BIOFINITY TORIC MULTIFOCAL (COMFILCON A)
• Manufacturer (Section D): COOPERVISION MANUFACTURING, LTD; south point , hamble unit 2; crendle@coopervision.co.uk; 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: 18383672
• MDR Text Key: 331292736
• Report Number: 9614392-2023-00039
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: R28799222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• 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
• Patient Age: 46 YR
• Patient Sex: Female