LIPIFLOW THERMAL PULSATION SYSTEM CONSOLE

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 2019-07-02 for LIPIFLOW THERMAL PULSATION SYSTEM CONSOLE manufactured by Johnson & Johnson Surgical Vision, Inc..

MAUDE Entry Details

• Report Number: 3008169506-2019-00004
• MDR Report Key: 8756398
• Report Source: FOREIGN,HEALTH PROFESSIONAL,U
• Date Received: 2019-07-02
• Date of Report: 2019-08-19
• Date of Event: 2019-05-27
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2019-07-24
• Date Added to Maude: 2019-07-02
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• 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: 22740 LUNN ROAD
• Manufacturer City: STRONGSVILLE OH 44149
• Manufacturer Country: US
• Manufacturer Postal Code: 44149
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LIPIFLOW THERMAL PULSATION SYSTEM CONSOLE
• Generic Name: LIPIFLOW
• Product Code: ORZ
• Date Received: 2019-07-02
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• 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	1. Required No Informationntervention	2019-07-02