LIPIFLOW ACTIVATOR II

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-10-12 for LIPIFLOW ACTIVATOR II manufactured by Johnson & Johnson Surgical Vision, Inc..

MAUDE Entry Details

• Report Number: 3008169506-2019-00008
• MDR Report Key: 9183159
• Report Source: FOREIGN,HEALTH PROFESSIONAL,U
• Date Received: 2019-10-12
• Date of Report: 2019-11-19
• Date of Event: 2019-09-20
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2019-10-21
• Date Added to Maude: 2019-10-12
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: SOMYATA NAGPAL
• Manufacturer Street: 1700 EAST ST. ANDREW PLACE
• Manufacturer City: SANTA ANA CA 92705
• Manufacturer Country: US
• Manufacturer Postal: 92705
• Manufacturer Phone: 7142478200
• Manufacturer G1: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Manufacturer Street: 510 COTTONWOOD DR
• Manufacturer City: MILPITAS CA 95035
• Manufacturer Country: US
• Manufacturer Postal Code: 95035
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LIPIFLOW ACTIVATOR II
• Generic Name: LIPIFLOW ACTIVATOR
• Product Code: ORZ
• Date Received: 2019-10-12
• Returned To Mfg: 2019-10-10
• Lot Number: 1804306
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Manufacturer Address: 1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-10-12