The Recall Desk

Manufacturer

Abbott Medical Optics Inc. (AMO)

19 recalls in our database name Abbott Medical Optics Inc. (AMO) as the manufacturing or recalling firm.

What the numbers show

Total
19
Critical
0
Severe
0
Most recent
2017-05-24

Of the 19 recalls from Abbott Medical Optics Inc. (AMO) we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–19 of 19

  • LowFDA (Devices)·Z-2096-2017·2017-05-24

    Abbott AMO Vitrectomy Cutters Recalled for Packaging Error

    Abbott Medical Optics is recalling 360 AMO Vitrectomy Cutters because 20GA and 25GA models may be packaged in the wrong sizes.

    Product
    AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2062-2017·2017-05-17

    Abbott Recalls Healon Medical Device Due to Glass Particle Risk

    Abbott Medical Optics is recalling Healon medical devices because certain lots may contain microscopic glass particles from manufacturing damage.

    Product
    Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2065-2017·2017-05-17

    Abbott Recalls Healon 5 Pro Due to Possible Glass Particles

    Abbott Medical Optics is recalling Healon 5 Pro ophthalmic solution because some units may contain microscopic glass particles from manufacturing damage.

    Product
    Healon 5 Pro, Part No. 10270015
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2063-2017·2017-05-17

    Abbott Recalls Healon GV Due to Possible Microscopic Glass Particles

    Abbott Medical Optics is recalling Healon GV due to a remote possibility of microscopic glass particles from manufacturing damage.

    Product
    Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2066-2017·2017-05-17

    Abbott Recalls Healon Pro Due to Possible Glass Particles

    Abbott Medical Optics is recalling Healon Pro ophthalmic solutions because manufacturing damage may have introduced microscopic glass particles.

    Product
    Healon Pro, Part No. 10270012
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2064-2017·2017-05-17

    Abbott Recalls Healon Duet Due to Potential Glass Particles

    Abbott Medical Optics is recalling Healon Duet units because they may contain microscopic glass particles from manufacturing damage.

    Product
    Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2857-2016·2016-09-28

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2858-2016·2016-09-28

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2860-2016·2016-09-28

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2863-2016·2016-09-28

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2864-2016·2016-09-28

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2855-2016·2016-09-28

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2862-2016·2016-09-28

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2859-2016·2016-09-28

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2856-2016·2016-09-28

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2861-2016·2016-09-28

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2015·2014-12-17

    Abbott Healon EndoCoat Ophthalmic Device Recalled for Finger Grip Defect

    Abbott Medical Optics is recalling Healon EndoCoat ophthalmic devices because the finger grip can dislodge, potentially causing eye trauma during surgery.

    Product
    Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging and Cannula Product of USA Abbott Healon Duet Dual Pack 0.55 ml OVD 0.85 ml Healon EndoCoat OVD Contents: -one sterile syringe of Hea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0929-2013·2013-03-20

    Abbott Recalls Mislabeled AMO Sensar Intraocular Lenses

    Abbott Medical Optics is recalling 155 AMO Sensar Intraocular Lenses because two production orders contained mislabeled units. The lenses are distributed worldwide.

    Product
    AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.
    Category
    Medical Device
    Distribution
    Distributed nationwide