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

Lot Number 12840170006026

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

Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Corneal Stromal Edema (1824); Acanthameba Keratitis (1945); Red Eye(s) (2038); Loss of Vision (2139); Corneal Infiltrates (2231)

Event Date 08/07/2023

Event Type  Injury  

Event Description

This incident was received by via medwatch (mw5148050), initially reported by treating physician, and limited information has been made available.According to the details provided, the patient experiences a central corneal ulcer that resulted in corneal scar, the physician indicates a patient outcome of unspecified permanent disability or damage.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 due to the indication of corneal ulcer with permanent injury.Should further information become available, a follow-up report will be submitted as appropriate.

Manufacturer Narrative

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 cooper vision 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.

Manufacturer Narrative

No root cause could be established.The relationship between the coopervision device and the incident is unconfirmed.New relevant medical information received 17 january 2024.Manufacturers incident report is updated to reflect new details.Refer to the following fields for updated or corrected data: a2, a3, b4, b5, g3, g6, h2, h4, h6, h8, h10.

Event Description

This incident was initially reported on 27 december 2023 as a corneal ulcer that resulted in permanent disability or damage, without supporting information.Additional medical information was received on january 17, 2024, from the treating healthcare professional.It was reported that the patient instilled a new lens on (b)(6), 2023, removing that same day with no overnight wear.The following day, the patient experienced unspecified symptoms in the left (os) eye and sought medical attention.Examination identified epithelial staining and edema, stromal edema, corneal infiltrates, and limbal and bulbar injection.The patient was diagnosed with an infectious corneal ulcer with infiltrates in the central cornea measuring 5 x 4.2mm.Corneal cultures taken returned positive for pseudomonas aeruginosa and serratia marcescens growth.The patient was treated with moxifloxacin, fortified tobramycin, and fortified vancomycin and seen for four follow-up visits.This issue has fully resolved as of august 23, 2023, however resulted with a central corneal opacity and permanent reduction in vision.Should further information become available, a follow-up report will be submitted as appropriate.

• 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: 18401662
• MDR Text Key: 331431209
• Report Number: 9614392-2023-00040
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2024
• Device Lot Number: 12840170006026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 31 YR
• Patient Sex: Male