30 results
·
53ms
·
Sources: EU EUDAMED, US FDA
LENSX LASER SYSTEM
FDA Adverse Event
Injury
·ALCON - LENSX LASERS, INC.·Product code OOE·March 25, 2013
LENSX LASER SYSTEM
FDA Adverse Event
Injury
·ALCON - LENSX LASER, INC.·Product code OOE·March 25, 2013
ENLIGHTEN III
FDA Adverse Event
Injury
·CUTERA, INC.·Product code GEX·May 23, 2025
LENSX LASER SYSTEM
FDA Adverse Event
Injury
·ALCON - LENSX LASERS, INC.·Product code OOE·April 25, 2012
LENSX LASER SYSTEM
FDA Adverse Event
Injury
·ALCON - LENSX LASERS, INC·Product code OOE·April 25, 2012
CATALYS SYSTEM
FDA Adverse Event
Injury
·AMO MANUFACTURING USA, LLC·Product code OOE·April 6, 2021
MERSILENE TAPE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·November 11, 2024
LIQUID OPTICS INTERFACE
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·May 19, 2023
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·February 27, 2024
CATALYS SYSTEM
FDA Adverse Event
Injury
·AMO MANUFACTURING USA, LLC·Product code OOE·June 15, 2022
TECNIS
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQL·May 4, 2020
American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic Hyperplasia). AMS Innovative Center, San Jose, CA 95134
FDA Recall
Terminated
·AMS Innovative Center San Jose·Product code GEX·June 18, 2007
BAERVELDT SHUNT
FDA Adverse Event
Injury
·AMO MANUFACTURING NETHERLANDS·Product code KYF·July 15, 2022
BAERVELDT SHUNT
FDA Adverse Event
Injury
·AMO MANUFACTURING NETHERLANDS·Product code KYF·July 15, 2022
BAERVELDT SHUNT
FDA Adverse Event
Malfunction
·AMO MANUFACTURING NETHERLANDS·Product code KYF·July 15, 2022
BAERVELDT SHUNT
FDA Adverse Event
Malfunction
·AMO MANUFACTURING NETHERLANDS·Product code KYF·July 15, 2022
GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight XPS Laser System, manufactured by American Medical Systems Inc., San Jose, CA The XPS Laser system is indicated for surgical incision and excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
FDA Recall
Terminated
·AMS Innovative Center San Jose·Product code GEX·July 14, 2010
TECNIS MULTIFOCAL
FDA Adverse Event
Injury
·AMO MANUFACTURING NETHERLANDS·Product code MFK·July 27, 2021
TECNIS SYMFONY
FDA Adverse Event
Injury
·AMO MANUFACTURING NETHERLANDS·Product code POE·July 27, 2021
CATALYS SYSTEM
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·March 8, 2019