FDA (Devices) recall action 75051

Abbott Medical Optics Inc. (AMO) recalled 10 products on 2016-09-28

The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.

Products: 10
Announced: 2016-09-28
Critical: 0
Units: 737

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–10 of 10

ModerateFDA (Devices)··2016-09-28
Abbott Recalls SENSAR Intraocular Lenses Due to Mislabeled Units
Abbott Medical Optics is recalling 84 SENSAR Foldable Intraocular Lenses because they were not checked prior to release, which may result in the release of mislabeled units.
Product
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 c
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ModerateFDA (Devices)··2016-09-28
Abbott Recalls TECNIS Multifocal Intraocular Lenses Due to Mislabeled Units
Abbott Medical Optics is recalling 77 TECNIS Multifocal Intraocular Lenses because they were not checked prior to release, potentially resulting in mislabeled products.
Product
TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extract
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ModerateFDA (Devices)··2016-09-28
Abbott Recalls TECNIS Intraocular Lenses Due to Mislabeled Units
Abbott Medical Optics is recalling 217 TECNIS 1-Piece Intraocular Lenses because they were not checked prior to release, potentially resulting in mislabeled products.
Product
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 inten
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ModerateFDA (Devices)··2016-09-28
Abbott Recalls TECNIS Symfony Intraocular Lenses Due to Mislabeled Units
Abbott Medical Optics is recalling 10 TECNIS Symfony intraocular lenses because they were not checked prior to release, potentially resulting in mislabeled products.
Product
TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction, and aph
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ModerateFDA (Devices)··2016-09-28
Abbott Recalls SENSAR Intraocular Lenses Due to Mislabeled Units
Abbott Medical Optics is recalling SENSAR 1-Piece Intraocular Lenses because they were not checked prior to release, which may result in the release of mislabeled units.
Product
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.
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ModerateFDA (Devices)··2016-09-28
Abbott Recalls 41 Intraocular Lenses Due to Mislabeled Product Risk
Abbott Medical Optics is recalling 41 TECNIS Multifocal Intraocular Lenses because they were not checked prior to release, posing a risk of mislabeling.
Product
TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extract
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ModerateFDA (Devices)··2016-09-28
Abbott Recalls Mislabeled Intraocular Lenses Due to Quality Control Failure
Abbott Medical Optics is recalling 41 intraocular lenses because they were not checked prior to release, potentially resulting in mislabeled products.
Product
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
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ModerateFDA (Devices)··2016-09-28
Abbott Recalls Intraocular Lenses Due to Mislabeled Product Release
Abbott Medical Optics is recalling 131 TECNIS OptiBlue intraocular lenses because they were not checked prior to release, potentially resulting in mislabeled products.
Product
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 i
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ModerateFDA (Devices)··2016-09-28
Abbott Recalls Intraocular Lenses Due to Mislabeled Units
Abbott Medical Optics is recalling 70 units of TECNIS OptiBlue Intraocular Lenses because they were not checked prior to release, potentially resulting in mislabeled products.
Product
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 le
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0 states
ModerateFDA (Devices)··2016-09-28
Abbott Recalls Mislabeled Intraocular Lenses Due to Quality Control Failure
Abbott Medical Optics is recalling 65 units of TECNIS 1-Piece Intraocular Lenses because they were not checked prior to release, potentially resulting in mislabeled products.
Product
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
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