Alcon Research, Ltd.
29 recalls on record · Latest: Aug 23, 2023
FDA Devices Moderate Aug 23, 2023
Centurion FMS Pak
FDA Devices Moderate Aug 23, 2023
Legion FMS Pak
FDA Devices Moderate Aug 23, 2023
Constellation Procedure Pak
FDA Devices Moderate Aug 23, 2023
Infinity FMS Pak
FDA Devices Moderate Aug 23, 2023
Alcon Custom Pak
FDA Devices Moderate Aug 23, 2023
Phaco Standalone Tips
FDA Devices Critical Oct 31, 2018
CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.
FDA Devices Critical Oct 31, 2018
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.
FDA Devices Moderate Mar 7, 2018
Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
FDA Devices Moderate Mar 7, 2018
Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a component.) Includes all necessary items for a core vitrectomy procedu…
FDA Devices Moderate Nov 8, 2017
Alcon Custom Pak
FDA Devices Moderate Sep 6, 2017
LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope Floor Stands are not stand-alone medical d…
FDA Devices Moderate Aug 30, 2017
ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
FDA Devices Moderate Aug 30, 2017
ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
FDA Devices Moderate Jul 6, 2016
CENTURION Vision System
FDA Devices Moderate May 25, 2016
23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 2…
FDA Devices Moderate May 25, 2016
Custom Paks containing 23G and 25G valved trocar cannula provide access into the posterior segment of the eye for surgical instruments within the fra…
FDA Devices Moderate May 25, 2016
Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G …
FDA Devices Moderate May 25, 2016
LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.
FDA Devices Moderate May 11, 2016
INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical syste…
FDA Devices Moderate Apr 20, 2016
VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance techn…
FDA Drug Moderate Feb 24, 2016
TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.03 FL OZ) Single-Use Vials, pac…
FDA Devices Critical Dec 2, 2015
Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and…
FDA Devices Moderate Nov 11, 2015
Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
FDA Devices Moderate Sep 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 t…
FDA Devices Moderate Jun 10, 2015
The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for s…
FDA Devices Moderate Dec 10, 2014
INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE. Model Numbers: 8065741080, 8065741081, 8065741082, 8065741083…
FDA Devices Moderate Oct 1, 2014
eye-pak 7407 Tray Support Cover REF 8065740745
FDA Devices Moderate Jul 9, 2014