BIOFINITY SPHERE (COMFILCON A)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-26 for BIOFINITY SPHERE (COMFILCON A) manufactured by Coopervision Manufacturing, Ltd..

MAUDE Entry Details

• Report Number: 9614392-2019-00033
• MDR Report Key: 9377972
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-11-26
• Date of Report: 2019-11-26
• Date of Event: 2019-10-25
• Date Mfgr Received: 2019-11-01
• Date Added to Maude: 2019-11-26
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. MELISSA TORPEY
• Manufacturer Street: 5870 STONERIDGE DRIVE SUITE 1
• Manufacturer City: PLEASANTON CA 94588
• Manufacturer Country: US
• Manufacturer Postal: 94588
• Manufacturer Phone: 5857569874
• Manufacturer G1: COOPERVISION MANUFACTURING, LTD.
• Manufacturer Street: SOUTH POINT HAMBLE UNIT 2
• Manufacturer City: SOUTHAMPTOM, HAMPSHIRE SO314RF
• Manufacturer Country: UK
• Manufacturer Postal Code: SO31 4RF
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BIOFINITY SPHERE (COMFILCON A)
• Generic Name: BIOFINITY SPHERE (COMFILCON A)
• Product Code: LPM
• Date Received: 2019-11-26
• Lot Number: 102907050082005
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COOPERVISION MANUFACTURING, LTD.
• Manufacturer Address: SOUTH POINT HAMBLE UNIT 2 SOUTHAMPTOM, HAMPSHIRE SO314RF UK SO31 4RF

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2019-11-26