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Abbott Medical Optics Inc. (AMO)

18 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrig recall (Z-2096-2017)Abbott Medical Optics Inc. (AMO)2017-05-16
SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for imp recall (Z-2855-2016)Abbott Medical Optics Inc. (AMO)2016-09-21
TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The product is indicat recall (Z-2856-2016)Abbott Medical Optics Inc. (AMO)2016-09-21
TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated prim recall (Z-2857-2016)Abbott Medical Optics Inc. (AMO)2016-09-21
TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantation for the visu recall (Z-2858-2016)Abbott Medical Optics Inc. (AMO)2016-09-21
TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated recall (Z-2859-2016)Abbott Medical Optics Inc. (AMO)2016-09-21
SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantation for the visu recall (Z-2860-2016)Abbott Medical Optics Inc. (AMO)2016-09-21
TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 The pro recall (Z-2861-2016)Abbott Medical Optics Inc. (AMO)2016-09-21
TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB0 recall (Z-2862-2016)Abbott Medical Optics Inc. (AMO)2016-09-21
TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indica recall (Z-2863-2016)Abbott Medical Optics Inc. (AMO)2016-09-21
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 The product is i recall (Z-2864-2016)Abbott Medical Optics Inc. (AMO)2016-09-21
Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg recall (Z-0530-2015)Abbott Medical Optics Inc (AMO)2014-12-12
AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Produ recall (Z-0929-2013)Abbott Medical Optics Inc (AMO)2013-03-09
Sensar Foldable IOL with OptiEdge. Model number AR40e, 6.0 Diopter. The Sensar Foldable IO recall (Z-0275-2012)Abbott Medical Optics Inc (AMO)2011-11-23
Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter. The Sensar Foldable IO recall (Z-0276-2012)Abbott Medical Optics Inc (AMO)2011-11-23
AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2 recall (Z-0129-2011)Abbott Medical Optics Inc (AMO)2010-11-02
AMO Total Care (1) Contact Lens Solution, Formula: 8772x; Product Code: 90275 (240 ml). Re recall (Z-0130-2011)Abbott Medical Optics Inc (AMO)2010-11-02
AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00) recall (Z-0605-2010)Abbott Medical Optics Inc (AMO)2010-01-12

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