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

Lot Number R18311675

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Iritis (1940); Keratitis (1944); Red Eye(s) (2038); Blurred Vision (2137)

Event Date 01/13/2021

Event Type  Injury  

Manufacturer Narrative

Lens sample received 19-feb, manufacturer investigation is ongoing.A follow-up report to be submitted on completion.

Event Description

It is reported that the patient developed blurred vision, redness, spk, and iritis in the right (od) eye while using the device.The patient was treated with tobradex for 10 days.The incident fully resolved with no permanent injury, however, the treating physician indicates that medical intervention and/or medication was required for the treatment of the iritis to prevent or preclude permanent injury or impairment of eye function or structure.

Manufacturer Narrative

(h3): no issues or non-conformances were found, no root cause could be established.The relationship between the coopervision device and the event is unconfirmed.

• Brand Name: BIOFINITY XR MULTIFOCAL TORIC (COMFILCON A)
• Type of Device: BIOFINITY XR MULTIFOCAL TORIC (COMFILCON A)
• Manufacturer (Section D): COOPERVISION MANUFACTURING, LTD.; south point; hamble unit 2; southamptom, hampshire SO31 4RF; UK SO31 4RF
• MDR Report Key: 11356007
• MDR Text Key: 232869566
• Report Number: 9614392-2021-00010
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• PMA/PMN Number: P080011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: R18311675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 59 YR