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Abbott Medical Optics Inc. (AMO) Recalls
19 recalls on record · March 20, 2013 to May 24, 2017 · Medical Devices
Recalls by year
13
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16
17
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 24, 2017Medical DevicesFDA
Abbott Medical Optics Inc. (AMO) recalls AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP
Hazard: Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package.
May 17, 2017Medical DevicesFDA
Abbott Medical Optics Inc. (AMO) recalls Healon V, Part No. 10290045
Hazard: Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
May 17, 2017Medical DevicesFDA
Abbott Medical Optics Inc. (AMO) recalls Healon Pro, Part No. 10270012
Hazard: Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
May 17, 2017Medical DevicesFDA
Abbott Medical Optics Inc. (AMO) recalls Healon 5 Pro, Part No. 10270015
Hazard: Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
May 17, 2017Medical DevicesFDA
Abbott Medical Optics Inc. (AMO) recalls Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012
Hazard: Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
May 17, 2017Medical DevicesFDA
Abbott Medical Optics Inc. (AMO) recalls Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
Hazard: Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
May 17, 2017Medical DevicesFDA
Abbott Medical Optics Inc. (AMO) recalls Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 102
Hazard: Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
September 28, 2016Medical DevicesFDA
Abbott Medical Optics Inc. (AMO) recalls AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 The product is indicated for implantation for
Hazard: Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
September 28, 2016Medical DevicesFDA
Abbott Medical Optics Inc. (AMO) recalls TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation
Hazard: Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
September 28, 2016Medical DevicesFDA
Abbott Medical Optics Inc. (AMO) recalls TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00V The product is indicated
Hazard: Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
September 28, 2016Medical DevicesFDA
Abbott Medical Optics Inc. (AMO) recalls TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 The product is indicated for implant
Hazard: Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
September 28, 2016Medical DevicesFDA
Abbott Medical Optics Inc. (AMO) recalls SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantation for the visual correction of aphakia in a
Hazard: Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
September 28, 2016Medical DevicesFDA
Abbott Medical Optics Inc. (AMO) recalls TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for implantation for the visu
Hazard: Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
September 28, 2016Medical DevicesFDA
Abbott Medical Optics Inc. (AMO) recalls TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantation for the visual correction of aphakia in a
Hazard: Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
September 28, 2016Medical DevicesFDA
Abbott Medical Optics Inc. (AMO) recalls TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated primary implantation for the visu
Hazard: Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
September 28, 2016Medical DevicesFDA
Abbott Medical Optics Inc. (AMO) recalls TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The product is indicated for primary implantation
Hazard: Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
September 28, 2016Medical DevicesFDA
Abbott Medical Optics Inc. (AMO) recalls SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual corr
Hazard: Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
December 17, 2014Medical DevicesFDA
Abbott Medical Optics Inc (AMO) recalls Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Ste
Hazard: AMO has received complaints where the finger grip dislodged while depressing the syringe plunger. The finger grip dislodgement could result in the surgeon's hand unintentionally moving the cannula further than intended, resulting in potential trauma to the eye.
March 20, 2013Medical DevicesFDA
Abbott Medical Optics Inc (AMO) recalls AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ult
Hazard: Two production orders of these IOLs that contain mislabeled IOLs.