BEUDAMED
    22 results · 41ms · Sources: EU EUDAMED, US FDA

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    ICE PACK LOADING CHUTE

    FDA Adverse Event
    Malfunction ·ANAGO, INC.·Product code IME·March 31, 1994

    ANAGO, ICE PACK

    FDA Adverse Event
    ANAGO·Product code KYR·July 18, 1994

    ANAGO, ICE PACK

    FDA Adverse Event
    ANAGO·Product code KYR·July 18, 1994

    ANAGO ICE PACK

    FDA Adverse Event
    Malfunction ·TECHNOL, INC.·Product code IMD·July 8, 1994

    ANAGO ICE PACK

    FDA Adverse Event
    Malfunction ·TECNOL, INC.·Product code IMD·September 8, 1994

    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

    STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.

    FDA Recall
    Terminated ·Abbott Medical Optics, Inc.·Product code LZS·September 16, 2013

    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

    STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.

    FDA Recall
    Terminated ·Abbott Medical Optics, Inc.·Product code LZS·September 16, 2013

    STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and distributed by AMO Manufacturing USA, LLC Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.

    FDA Recall
    Terminated ·Abbott Medical Optics, Inc.·Product code LZS·September 16, 2013

    STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.

    FDA Recall
    Terminated ·Abbott Medical Optics, Inc.·Product code LZS·September 16, 2013

    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

    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 extraction and who desire near, intermediate, and distance vision with increased spectacle independence. 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 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 aphakia following refractive lensectomy in presbyopic adults, who desire useful vision over a continuous range of distances including far, intermediate and near, and increased spectacle independence. 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 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 extraction and who desire near, intermediate, and distance vision with increased spectacle independence. 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

    Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers: 20003D/J/K, R20003D/J/K, 20005D/J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code HNO·October 12, 2011