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

Lot Number 12491000085026

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

Patient Problems Corneal Ulcer (1796); Corneal Infiltrates (2231); Eye Pain (4467); Insufficient Information (4580)

Event Date 09/17/2022

Event Type  Injury  

Manufacturer Narrative

No device sample was returned for manufacturer analysis.A lot number was provided for the device alleged to be involved in the incident.Investigation found no issues or nonconformance's and no trends were identified.No root cause could be established.The relationship between the coopervision device and the incident is unconfirmed.Should additional information become available, coopervision will complete additional investigations and submit a follow-up report as appropriate.

Event Description

This incident was reported by the patients location of purchase as related by the patient, limited information has been made available.It was reported that the patient visited the (b)(6) hospital for an emergency visit and was diagnosed by a doctor (b)(6) with corneal ulcer in the left (os) eye.It is reported that the patient had the lens analysed by a laboratory and the presence of bacteria was identified.Contact information for the testing laboratory and/or a copy of the results have not been provided.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 lack of medical information, unconfirmed diagnosis, and unknown patient resolution.Should further information become available, a follow-up report will be submitted as appropriate.

Event Description

This incident was initially reported by patient's location of purchase.It was reported that the patient visited the dijon university hospital for an emergency visit and was diagnosed by a doctor hurand victoire with corneal ulcer in the left (os) eye.It is reported that the patient had the lens analysed by a laboratory and the presence of bacteria was identified.Good faith efforts have been made to obtain further information without success.As of the date of initial report, additional information was unknown.Further medical information received 27 october from the treating physician, doctor hurand victoire.The patient was seen for several visits between onset ((b)(6)) and date of medical report provided (27 oct).The patient sought urgent medical care for eye pain and presented with severe epithelial staining, corneal infiltrates and epithelial and stromal edema.Fluorescein staining identified a lower inferior paracentral infiltrative corneal ulcer approximately 1.7x1.7mm in size.The contact lens from the left eye as well as corneal scraping cultures were sent for testing where the presence of pseudomonas aeruginosa, stenotrophomonas maltophilia (formerly xanthomonas), delftia acidovaroans (formerly comamonas), klebsiella oxytoca, and bacillus species were identified.The patient was treated with vancomycin + ceftazidime, tobramycin + ciprofloxacin, and neomycin + ciprofloxacin.As of the date of report, treatment is ongoing.The physician indicates temporary decrease in visual acuity, superficial epithelial damage, and tyndall.

Manufacturer Narrative

No root cause could be established.The relationship between the coopervision device and the incident is unconfirmed.Should additional information become available, coopervision will complete additional investigations and submit a follow-up report 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; southamptom, hampshire SO31 4RF; UK SO31 4RF
• Manufacturer (Section G): COOPERVISION MANUFACTURING, LTD.; south point; hamble unit 2; southamptom, hampshire SO31 4RF; UK SO31 4RF
• Manufacturer Contact: melissa torpey ; 209 high point drive; suite 100; victor, NY 14564 ; 5857569874
• MDR Report Key: 15680979
• MDR Text Key: 302494573
• Report Number: 9614392-2022-00025
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P080011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 12491000085026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 37 YR
• Patient Sex: Female