1,000 results
·
73ms
·
Sources: EU EUDAMED, US FDA
ABBOTT MEDICAL OPTICS INC. CARTRIDGE
FDA Adverse Event
Injury
·ABBOTT·Product code KYB·September 7, 2017
TECNIS CL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·November 6, 2012
CEEON
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·March 14, 2016
PHACO MACHINE WHITESTAR SIGNATURE SYSTEM
FDA Adverse Event
Injury
·AMO MANUFACTURING USA, LLC·Product code HQC·December 3, 2021
TECNIS
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code MFK·March 11, 2016
Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the item necessary to perform one vitrectomy procedure. It is used to remove vitreous from the eye. It has been designed as a disposable (single use)
FDA Recall
Terminated
·Johnson & Johnson Surgical Vision Inc·Product code MLZ·September 24, 2018
Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the item necessary to perform one vitrectomy procedure. It is used to remove vitreous from the eye. It has been designed as a disposable (single use)
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Surgical Vision Inc·July 10, 2019
TECNIS CL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·December 5, 2012
TECNIS 1 MULTIFOCAL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code MFK·November 6, 2012
Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.
FDA Recall
Terminated
·Abbott Medical Optics Inc (AMO)·Product code HQL·September 20, 2011
Sensar Foldable IOL with OptiEdge. Model number AR40e, 6.0 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.
FDA Recall
Terminated
·Abbott Medical Optics Inc (AMO)·Product code HQL·September 20, 2011
TECNIS CL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·October 17, 2012
TECNIS CL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·October 17, 2012
SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
FDA Recall
Terminated
·Abbott Medical Optics Inc. (AMO)·Product code HQL·August 26, 2016
TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
FDA Recall
Terminated
·Abbott Medical Optics Inc. (AMO)·Product code HQL·August 26, 2016
TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag
FDA Recall
Terminated
·Abbott Medical Optics Inc. (AMO)·Product code HQL·August 26, 2016
SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
FDA Recall
Terminated
·Abbott Medical Optics Inc. (AMO)·Product code HQL·August 26, 2016
TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00V The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag
FDA Recall
Terminated
·Abbott Medical Optics Inc. (AMO)·Product code HQL·August 26, 2016
TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
FDA Recall
Terminated
·Abbott Medical Optics Inc. (AMO)·Product code HQL·August 26, 2016
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
FDA Recall
Terminated
·Abbott Medical Optics Inc. (AMO)·Product code HQL·August 26, 2016