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

Lot Number 122430000835190010

Device Problem Material Separation (1562)

Patient Problem Eye Infections (4466)

Event Type  Injury  

Event Description

The patient reported that our lenses caused an infection in their eye from a lens that tore while wearing them.The user sought medical attention to remove the lens.This incident was reported to the manufacturer by the patient.No medical information has been provided by the treating physician(s), or the care facility.Good faith efforts have been made to obtain additional information without success, as of the date of this report additional information is unknown.This event is being reported with an abundance of caution due to the alleged infection with a lack of medical information, unconfirmed diagnosis, and unknown patient resolution.Should further information become available, a follow-up report will be submitted as appropriate.This event is being reported in the us and does not meet the minimum criteria of a reportable adverse event in any other country or region where the product is sold.

Manufacturer Narrative

The returned device was in a damaged state and the manufacturer was unable to complete further testing or analysis of the returned sample.As the lens was returned opened and in used damaged condition, the lens damage could not be positively identified as a manufacturing or packaging failure or malfunction.The lot number was provided, and the lot history, device history, sterilization records, and trend reporting were reviewed.No issues or non-conformances were found and, no trends were identified, no root cause could be established.

• Brand Name: BIOFINITY TORIC (COMFILCON A)
• Type of Device: BIOFINITY TORIC (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: jose rodriguez ; 209 high point dr; victor, NY 14564 ; 5857569847
• MDR Report Key: 15438569
• MDR Text Key: 300052559
• Report Number: 9614392-2022-00021
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 122430000835190010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Date Manufacturer Received: 08/19/2022
• 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