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

Lot Number 12861500089016

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abrasion (1689); Eye Infections (4466); Eye Pain (4467)

Event Type  Injury  

Event Description

This incident was reported by the patient, limited information has been made available.The patient states they visited a health professional and was told he had scratches and an infection then was prescribed eye drops.The patient states this occurred a total of six times.The patients location of purchase states the patient has preexisting condition but the patient has not been seen or treated at their location for an eye infection.Patient declined to provide contact information or authorization to contact treating physician.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.

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 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.

• 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: 16277315
• MDR Text Key: 308541228
• Report Number: 2640128-2023-00001
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Lot Number: 12861500089016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2023
• 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: 66 YR
• Patient Sex: Male