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

Lot Number R27693370

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

Patient Problems Eye Injury (1845); Visual Impairment (2138); Eye Pain (4467); Unspecified Eye / Vision Problem (4471); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

H3: device sample was returned for manufacturer analysis and received on 27 september 2023.Inspection results and investigation are still pending.Upon completion of device analysis and investigation, a follow-up report with results will be submitted.

Event Description

This incident was reported by eye care practitioner to the manufacturer.It was reported that patient experienced pain, irritation, redness, poor vision.It was alleged that patient was diagnosed with an unspecified medical event, corneal damage.It is reported though that the incident has resolved without any permanent damage and the patient has resumed lens use.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 nature and severity of the incident, unconfirmed diagnosis, and the lack of supporting medical information.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 27 september 2023 and investigation completed 12 october 2023.

• Brand Name: BIOFINITY XR TORIC (MTO) (COMFILCON A)
• Type of Device: BIOFINITY XR TORIC (MTO) (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 ; 5857569688
• MDR Report Key: 17914127
• MDR Text Key: 325411829
• Report Number: 9614392-2023-00030
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: LH
• 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: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: R27693370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2023
• 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