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

Lot Number 12816070010509

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

Patient Problems Corneal Ulcer (1796); Corneal Stromal Edema (1824); Red Eye(s) (2038); Eye Infections (4466); Eye Pain (4467)

Event Date 09/27/2023

Event Type  Injury  

Event Description

Patient was wearing biofinity toric (comfilcon a) soft contact lens (power: +2.25d/-1.75x180) in her left eye on an extended wear modality.Wearing frequency was 5-7 days per week, frequent usage.It is reported that the patient instilled a new contact lens the night prior to onset.The patient woke the following day with symptoms of ocular pain, redness, discharge, and photophobia.Patient saw an optometrist the same day of onset, 27 september.Examination showed left eye lid oedema, grade 3 conjunctival hyperaemia, mild stromal oedema, anterior chamber cells, and keratic precipitates.The patient was diagnosed with a 1mm circular mid-peripheral corneal ulcer of the left eye in the 7 o'clock area.Patient was initially treated with ciprofloxacin and dexamethasone was added on (b)(6) 2023.Since that date, the treating specialist had indicated cessation of the ciprofloxacin and patient is currently being tapered off dexamethasone.As of the date of this report, treatment is ongoing however, all symptoms have fully resolved as of 09 november 2023.As of the date of this report additional information is unknown.This event is being reported due to the corneal ulcer diagnosis with medical interventions and medications prescribed.Should further information become available, a follow-up report will be submitted as appropriate.

Manufacturer Narrative

(see h3) 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 coopervision 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

Device sample returned for analysis, received 8 december 2023 and analysis completed on 13 december 2023.Manufacturers incident report is updated to reflect the results of device analysis and investigations.Refer to the following fields for updated or corrected data: b4,b6,d9,e4,g2,g3,g6,h2,h3,h4,h6.Based on manufacturer analysis of the returned device(s) and investigation, no root cause could be established.The relationship between the coopervision device and the event is unconfirmed.Should additional information become available additional investigation will be completed and a follow-up 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: 18275559
• MDR Text Key: 329844720
• Report Number: 9614392-2023-00034
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P080011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 12816070010509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• 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; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female