89 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LIQUID OPTICS INTERFACE
FDA UDI
OPTIMEDICA CORPORATION·05050474604803·LIQUID OPTICS(TM) INTRFACE, STERILE, SGL
CATALYS SYSTEM
FDA UDI
OPTIMEDICA CORPORATION·05050474609792·CATALYS SYSTEM, US
LIQUID OPTICS INTERFACE
FDA UDI
OPTIMEDICA CORPORATION·05050474604827·LIQUID OPTICS INTRFC,STERILE, BULK PK,20
CATALYS SYSTEM
FDA UDI
OPTIMEDICA CORPORATION·05050474709508·CATALYS ELEVATED SYS ACCY,USE W/MPB,US
LIQUID OPTICS INTERFACE
FDA UDI
OPTIMEDICA CORPORATION·05050474604834·LIQUID OPTICS INTRFCE,12,BK PK,20 UNITS
LIQUID OPTICS INTERFACE
FDA UDI
OPTIMEDICA CORPORATION·05050474604810·SINGLE LIQUID OPTICS INTERFACE,12
PASCAL PHOTOCOAGULATOR
FDA Adverse Event
Malfunction
·OPTIMEDICA CORPORATION·Product code GEX·April 17, 2008
OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers: 46120916; 46123116, 46124617; 46131418, and 46131618 label states "Manufactured for: OptiMedica Corporation 510 Cottonwood Drive Milpitas, CA 95035 USA The Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Surgical Vision Inc·October 10, 2018
CATALYS PRECISION LASER SYSTEM
FDA Adverse Event
Injury
·OPTIMEDICA CORPORATION·Product code OOE·June 5, 2014
CATALYS PRECISION LASER SYS
FDA Adverse Event
Injury
·OPTIMEDICA CORPORATION·Product code OOE·May 22, 2014
CATALYS PRECISION LASER SYSTEM
FDA Adverse Event
Injury
·OPTIMEDICA CORPORATION·Product code OOE·April 25, 2014
CATALYS PRECISION LASER SYSTEM
FDA Adverse Event
Injury
·OPTIMEDICA CORPORATION·Product code OOE·June 12, 2014
CATALYS PRECISION LASER SYSTEM
FDA Adverse Event
Injury
·OPTIMEDICA CORPORATION·Product code OOE·June 12, 2014
CATALYS PRECISION LASER SYSTEM
FDA Adverse Event
Injury
·OPTIMEDICA CORPORATION·Product code OOE·April 21, 2014
CATALYS PRECISION LASER SYSTEM
FDA Adverse Event
Injury
·OPTIMEDICA CORPORATION·Product code OOE·June 25, 2014
CATALYS PRECISION LASER SYSTEM
FDA Adverse Event
Injury
·OPTIMEDICA CORPORATION·Product code OOE·April 9, 2014
CATALYS PRECISION LASER SYSTEM
FDA Adverse Event
Injury
·OPTIMEDICA CORPORATION·Product code OOE·June 5, 2014
CATALYS PRECISION LASER SYS
FDA Adverse Event
Injury
·OPTIMEDICA CORPORATION·Product code OOE·May 20, 2014
CATALYS PRECISION LASER SYSTEM
FDA Adverse Event
Injury
·OPTIMEDICA CORPORATION·Product code OOE·April 30, 2014
CATALYS PRECISION LASER SYSTEM
FDA Adverse Event
Injury
·OPTIMEDICA CORPORATION·Product code OOE·November 25, 2014