MAUDE Adverse Event Report: COOPERVISION MANUFACTURING PUERTO RICO, LLC BIOFINITY TORIC (COMFILCON A)

Lot Number 12240570039008

Device Problem Insufficient Information (3190)

Patient Problems Corneal Ulcer (1796); Eye Pain (4467)

Event Type  Injury  

Manufacturer Narrative

No device sample was returned for manufacturer analysis.Investigation of the provided lot number found no issues or non-conformances and no trends were identified.No root cause could be established.The relationship between the coopervision device and the event is unconfirmed.Should additional information become available, a follow-up report will be submitted as appropriated.As the impacted eye is unspecified and patient was using a different device in each eye, please refer to linked manufacturer report (b)(6) 2640128-2023-00009 for associated incident report.

Event Description

This incident was reported to the manufacturer by the patient and limited information has been made available.The patient reported experiencing pain in both eyes and a lens that developed a film on it.The patient alleges she sought medical attention and was diagnosed with a corneal ulcer in one eye (unspecified) and was unsure if it was related to lens wear.The manufacturer made contact with the eye care provider contact information provided by the patient who stated the patient had not been examined in their office.No other physician or treating location information has 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 alleged corneal ulcer diagnosis with unknown nature or severity of the incident, lack of supporting medical information and unknown patient resolution.Should further information become available, a follow-up report will be submitted as appropriate.As the impacted eye is unspecified and patient was using a different device in each eye, please refer to linked manufacturer report (b)(6) 2640128-2023-00009 for associated incident report.

• Brand Name: BIOFINITY TORIC (COMFILCON A)
• Type of Device: BIOFINITY TORIC (COMFILCON A)
• Manufacturer (Section D): COOPERVISION MANUFACTURING PUERTO RICO, LLC; 500 road 584 lot 7; amuelas industrial park, juana diaz 00795 ; * 00795
• Manufacturer (Section G): COOPERVISION MANUFACTURING PUERTO RICO, LLC; 500 road 584 lot 7; amuelas industrial park, juana diaz 00795 ; * 00795
• Manufacturer Contact: jose rodriguez ; 209 high point dr; victor, NY 14564 ; 5857569847
• MDR Report Key: 17948927
• MDR Text Key: 325827795
• Report Number: 2640128-2023-00010
• 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: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 12240570039008
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2023
• 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: 53 YR
• Patient Sex: Female