MAUDE Adverse Event Report: COOPERVISION, INC. BIOFINITY TORIC MULTIFOCAL (COMFILCON A)

Lot Number RB0013186

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

Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Burning Sensation (2146); Eye Infections (4466)

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.Lot history, device history, sterilization records, and trend reporting were reviewed.No issues or nonconformance's were found 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 end user to the manufacturer with additional information received from the treating ophthalmologist.The patient states that beginning in (b)(6) 2022, they experienced a burning sensation upon instilling contact lenses and were diagnosed with two eye infections in the left eye (os), one resulted in small scar and two months later experienced a second, that resulted in an ulcer.At the time of report, the patient states the second incident is still resolving.Information received from the ophthalmologist states the patient was seen on (b)(6) 2022, for the first incident, and treated for a central corneal ulcer of the left eye.Good faith efforts have been made to obtain further information without success.As of the date of this report, additional information is unknown.This event is being reported in 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.

• Brand Name: BIOFINITY TORIC MULTIFOCAL (COMFILCON A)
• Type of Device: BIOFINITY TORIC MULTIFOCAL (COMFILCON A)
• Manufacturer (Section D): COOPERVISION, INC.; 711 north road; scottsville NY 14546
• Manufacturer (Section G): COOPERVISION, INC.; 711 north road; scottsville NY 14546
• Manufacturer Contact: spandana mannepalli ; 209 highpoint drive; suite 100; victor, NY 14564 ; 5857569688
• MDR Report Key: 16540358
• MDR Text Key: 311263156
• Report Number: 1314956-2023-00003
• 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
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: RB0013186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2023
• 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 Sex: Male