CATALYS SYSTEM CATALYS-I CATALYS-U

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-28 for CATALYS SYSTEM CATALYS-I CATALYS-U manufactured by Johnson & Johnson Surgical Vision, Inc..

MAUDE Entry Details

Report Number3005675890-2020-00003
MDR Report Key9640135
Date Received2020-01-28
Date of Report2020-01-28
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2005-01-14
Date Added to Maude2020-01-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactSOMYATA NAGPAL
Manufacturer Street1700 EAST ST. ANDREW PLACE
Manufacturer CitySANTA ANA CA 92705
Manufacturer CountryUS
Manufacturer Postal92705
Manufacturer Phone7142478200
Manufacturer G1JOHNSON & JOHNSON SURGICAL VISION, INC.
Manufacturer Street510 COTTONWOOD DRIVE
Manufacturer CityMILPITAS CA 95035
Manufacturer CountryUS
Manufacturer Postal Code95035
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameCATALYS SYSTEM
Generic NameCATALYS
Product CodeOOE
Date Received2020-01-28
Model NumberCATALYS-I
Catalog NumberCATALYS-U
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerJOHNSON & JOHNSON SURGICAL VISION, INC.
Manufacturer Address1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705

Device Sequence Number: 101

Product Code---
Date Received2020-01-28
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-28

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