BEUDAMED
    34 results · 28ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Centurion FMS Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023

    Legion FMS Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023

    Phaco Standalone Tips

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023

    Constellation Procedure Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023

    Infinity FMS Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023

    ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·August 30, 2017

    Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·January 18, 2017

    Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space and replace fluids that are lost during surgery.

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·July 9, 2014

    CENTURION Vision System

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·July 6, 2016

    INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·May 11, 2016

    ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·August 30, 2017

    Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only. Intended to provide the surgeon with a single-use probe for performing vitrectomy surgical procedures while using the Alcon Accurus vitrectomy console.

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·July 8, 2015

    This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Constellation 23G Total PLUS Pak, Constellation 23G Combined Pack (0.9 mm and 1.1 mm) and 23G Small Parts Kit. Single use 23G non-valved trocar cannulas are used to provide internal access to the ocular cavity during ophthalmic surgery. Single use infusion cannulas are used for the infusion of fluid or air during ophthalmic surgery to maintain intraocular pressure during posterior segment surgeries.

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LTD.·October 3, 2012

    LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product Usage: The LX3 Microscope Floor Stand is an accessory to the LuxOR Opthalmic Microscope and the LuxOR Opthalmic Microscope with Q-VUE 3-D Assistant Visualization and provides a portable suspension system for the microscope that integrates an AC power module and microscope controls (Primary Control Panel and connectivity of foot controllers)

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·September 2, 2015

    Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·November 11, 2015

    VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed to provide greater accuracy and efficiency during cataract surgery. It allows eye surgeons to capture a high-resolution, diagnostic reference image of the patients eye pre-operatively, quickly determine an optimized surgical plan that enables surgeons to see all inclusions and alignment in real-time.

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·April 20, 2016

    LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·May 25, 2016

    LAUREATE World Phaco System

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·September 21, 2016

    Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior chamber lens for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients following cataract surgery. This material is capable of being folded prior to insertion. The lens gently unfolds to a fullsize lens body following implantation. The lens has a biconvex optic with supporting haptics The AcrySof IQ IOLs are provided in the ULTRASERT Preloaded Delivery System for a convenient, controlled means to reliably place these lenses into the capsular bag.

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·September 7, 2016