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

Device Problem Insufficient Information (3190)

Patient Problem Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

No device sample returned for manufacturer analysis and no lot number reported, no investigation could be completed, and no root cause established.The relationship between the coopervision device and the incident is unconfirmed.

Event Description

Information received from the patient's location of purchase, online retailer.It is reported that the patient sought emergency medical attention for stinging and burning and was treated for toxic keratitis of the cornea, it is stated that vision was decreased and patient was legally blind for the following two to three days.Contact information was provided for the patient was permission to contact.Good faith efforts were maid to obtain additional information from the patient on the incident and medical treatment received without success, further information is unknown.This event is being reported in an abundance of caution due to unconfirmed diagnosis, lack of medical information, and unknown resolution.

• 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 ; 5870 stoneridge drive; suite 1; pleasanton, CA 94588 ; 5857569874
• MDR Report Key: 11791030
• MDR Text Key: 249503869
• Report Number: 9614392-2021-00016
• 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: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other