BLINK REVITALENS 09608X

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-29 for BLINK REVITALENS 09608X manufactured by Johnson & Johnson Surgical Vision, Inc..

MAUDE Entry Details

• Report Number: 3004537773-2019-00001
• MDR Report Key: 8839669
• Date Received: 2019-07-29
• Date of Report: 2019-07-29
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2019-06-11
• Device Manufacturer Date: 2015-03-25
• Date Added to Maude: 2019-07-29
• 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: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. 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: CTRA. FUENCARRAL-ALCOBENDAS KM APARTO 92
• Manufacturer City: MADRID 28100ALC
• Manufacturer Country: ES
• Manufacturer Postal Code: 28100 ALCO
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: BLINK REVITALENS
• Generic Name: SOLUTIONS
• Product Code: LPN
• Date Received: 2019-07-29
• Model Number: 09608X
• Lot Number: AA04792
• Device Expiration Date: 2017-03-31
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• 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	2019-07-29