85 results
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Sources: EU EUDAMED, US FDA
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PurePoint System Operator's Manual, Catalog Number 8065751131, Rev. B for use with the Alcon PurePoint Laser, Catalog Number 8065750597 Indicated for use in photocoagulation of both anterior and posterior segments of the eye.
FDA Recall
Terminated
·Alcon Laboratories, Inc.·Product code HQF·September 26, 2008
Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code LRO·September 21, 2015
23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code NGY·August 11, 2015
LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope Floor Stands are not stand-alone medical devices, but are used in combination with the LuxOR Ophthalmic Microscope and the LuxOR Ophthalmic Microscope with Q-VUE 3-D Assistant Visualization. These microscopes are used for low magnification visualization during cataract, retina, and cornea surgeries
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code HRM·May 25, 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 Recall
Terminated
·Alcon Research, Ltd.·Product code LRO·May 16, 2014
Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code MSS·September 5, 2016
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 Recall
Terminated
·Alcon Research, Ltd.·Product code NFG·March 1, 2016
ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code NCF·June 30, 2017
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.
FDA Recall
Terminated
·Alcon Research, LTD.·Product code OGO·August 28, 2018
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 Recall
Terminated
·Alcon Research, Ltd.·Product code HQC·June 2, 2015
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 Recall
Terminated
·Alcon Research, Ltd.·Product code HRM·August 11, 2015
CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.
FDA Recall
Terminated
·Alcon Research, LTD.·Product code OGO·August 28, 2018
ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code NCF·June 30, 2017
Opthalmic Laser, product number 8065-5000-1
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code HQF·April 9, 2004
19 Gauge Trocar Cannula Replacement Plug, Catalog Number 617.32; Manufactured by Alcon Grieshaber, Ltd., Schaffhauxen, Switzerland CH8203.
FDA Recall
Terminated
·Alcon Research, Ltd·Product code NGY·January 18, 2007
The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code LRO·April 28, 2015
Lasik Custom Pak containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye, ocucel, 5S, PVA, 1 cover, support, tray 2.2MIL 6FD, and 2 dressings, tegaderm, 2 3/8 x 2 3/4. All contents considered sterile unless package is opened or damaged.RX Only. Part number 10162-01. (The Vidaurri LASIK Flap Irrigators are included in the firm''s Alcon Custom Pak Part Number 10162-01 under the description of dual tip irrigator, 8 ports, 16G.)
FDA Recall
Terminated
·Alcon Research, Ltd·Product code LQJ·September 2, 2005
INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code HQC·October 6, 2014
Alcon/Grieshaber Morris ILM Forceps, Direct Action; Manual ophthalmic surgical instrument, Catalog Number: 641.22; Non-sterile/Reusable; Alcon Laboratories, Inc., Fort Worth, TX 76134.
FDA Recall
Terminated
·Alcon Research, Ltd·Product code HNR·March 7, 2008
ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan.
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code HQL·April 15, 2015