Alcon Research LLC
Medical device manufacturer in Fort Worth, TX.
17510(k) clearances
7PMA approvals
109recalls
Device types
- HQC Unit, Phacofragmentation 4
- MSS Folders And Injectors, Intraocular Lens (Iol) 2
- LPN Accessories, Soft Lens Products 2
- MLZ Vitrectomy, Instrument Cutter 2
- GEX Powered Laser Surgical Instrument 2
- KYB Lens, Guide, Intraocular 1
- NCF Aberrometer, Ophthalmic 1
- HNN Knife, Ophthalmic 1
- HQB Photocoagulator And Accessories 1
- HQE Instrument, Vitreous Aspiration And… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K191650 | LEGION SystemHQC · Traditional | 11/01/2019SE |
| K161794 | CENTURION Vision System (Active SentryTM)HQC · Traditional | 04/14/2017SE |
| K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy…MLZ · Special | 03/22/2017SE |
| K141065 | Constellation Vision SystemHQE · Traditional | 08/22/2014SE |
| K121031 | Wavelight FS200 Patient Interface 1505GEX · Abbreviated | 06/21/2012SE |
| K112977 | Monarch III Iol Delivery System, Monarch III C Cartridge, Monarch III Handpiece (H4)MSS · Abbreviated | 03/27/2012SE |
| K110951 | 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved…HQB · Traditional | 10/17/2011SE |
| K110166 | Clearcut S Safety KnifeHNN · Abbreviated | 05/20/2011SE |
| K102860 | Alcon Multi-Pirpose Disinfecting SolutionLPN · Traditional | 05/10/2011SE |
| K101006 | Wavelight FS200 Laser System Model: FS200GEX · Traditional | 10/21/2010SE |
| K093305 | Enhanced Ultra Vit ProbeMLZ · Traditional | 04/02/2010SE |
| K091777 | Alcon UltrachopperHQC · Traditional | 10/20/2009SE |
| K082845 | Infiniti Vision System with Ozil IpHQC · Traditional | 02/12/2009SE |
| K062930 | Ladarwave Customcornea Wavefront SystemNCF · Abbreviated | 11/08/2006SE |
| K050729 | Alcon Multi-Purpose Disinfecting SolutionLPN · Traditional | 09/14/2005SE |
| K003768 | Monarch II Iol Delivery SystemMSS · Abbreviated | 01/05/2001SE |
| K001157 | Monarch II Iol Delivery SystemKYB · Traditional | 06/27/2000SE |
PMA approvals
- P230012 UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy · 08/26/2024 · 10 supplements
- P220030 UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery · 07/02/2024 · 10 supplements
- P170034 Hydrus Microstent · 08/10/2018 · 17 supplements
- P150037 CyPass Micro-Stent · 07/29/2016 · 12 supplements
- P040020 Acrysof Restor Apodized Diffractive Optic Posterior Chamber Iol · 03/21/2005 · 118 supplements
- P890047 Provisc(Tm)Viscoelastic Preparation · 09/26/1991 · 67 supplements
- P830040 Styles 30 & 31 Posterior Chamber Iols · 09/05/1985 · 18 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0939-2026 Class I | Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers:…Ophthalmic procedure packs may have incomplete seals affecting sterility. | 11/24/2025Open, Classified |
| Z-0326-2026 Class II | Alcon PRECISION1 One-Day Contact Lenses, -2.25D.Potential for a weak seal in some units resulting in compromise in sterility. | 09/30/2025Open, Classified |
| Z-0581-2026 Class II | CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+…XXX | 09/15/2025Open, Classified |
| Z-0308-2026 Class II | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and…Due to incomplete seals in the pouch which provide the sterile barrier. | 08/05/2025Open, Classified |
| Z-0307-2026 Class II | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and…Due to incomplete seals in the pouch which provide the sterile barrier. | 08/05/2025Open, Classified |
| Z-0306-2026 Class II | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and…Due to incomplete seals in the pouch which provide the sterile barrier. | 08/05/2025Open, Classified |
| Z-0305-2026 Class II | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and…Due to incomplete seals in the pouch which provide the sterile barrier. | 08/05/2025Open, Classified |
| Z-0304-2026 Class II | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and…Due to incomplete seals in the pouch which provide the sterile barrier. | 08/05/2025Open, Classified |
| Z-2110-2025 Class II | Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many…Due to the potential that some units within specific lots were damaged during the manufacturing process. The… | 04/28/2025Open, Classified |
| Z-2109-2025 Class II | Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined…Due to the potential that some units within specific lots were damaged during the manufacturing process. The… | 04/28/2025Open, Classified |
| Z-2108-2025 Class II | Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System…Due to the potential that some units within specific lots were damaged during the manufacturing process. The… | 04/28/2025Open, Classified |
| Z-1293-2025 Class II | Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09…Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content… | 02/10/2025Open, Classified |
| Z-0835-2025 Class II | Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number:…Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which… | 11/13/2024Open, Classified |
| Z-0490-2025 Class III | a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11…Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to… | 10/15/2024Open, Classified |
| Z-3313-2024 Class II | DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,Material with a quality issue was used in contact lens production, so contact lenses may not meet quality… | 08/08/2024Open, Classified |
| Z-2680-2024 Class II | Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2679-2024 Class II | Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2678-2024 Class II | Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2677-2024 Class II | Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2676-2024 Class II | Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2675-2024 Class II | Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2674-2024 Class II | Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2673-2024 Class II | Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2672-2024 Class II | Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2671-2024 Class II | Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2670-2024 Class II | Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Catalog…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2669-2024 Class II | Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Catalog…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2668-2024 Class II | Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2667-2024 Class II | Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Catalog…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2666-2024 Class II | Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Model/Catalog…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2665-2024 Class II | Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Catalog…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2664-2024 Class II | Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number:…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2663-2024 Class II | Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number:…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2662-2024 Class II | Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number:…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2661-2024 Class II | Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2660-2024 Class II | Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog Number:…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2659-2024 Class II | Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number:…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2658-2024 Class II | Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2657-2024 Class II | Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2656-2024 Class II | Product Desc: Product Name: 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2655-2024 Class II | Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2654-2024 Class II | Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog Number:…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2653-2024 Class II | Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Model/Catalog Number:…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2652-2024 Class II | Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Number:…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2651-2024 Class II | Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2 Model/Catalog Number:…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2650-2024 Class II | Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2 Model/Catalog Number:…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2649-2024 Class II | Product Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2648-2024 Class II | Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2647-2024 Class II | Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 8065830077 Software…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2646-2024 Class II | Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2645-2024 Class II | Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number:…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 07/15/2024Open, Classified |
| Z-2412-2024 Class II | Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization…After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs… | 05/23/2024Open, Classified |
| Z-1925-2024 Class II | ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 04/22/2024Open, Classified |
| Z-1924-2024 Class II | ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 04/22/2024Open, Classified |
| Z-1923-2024 Class II | ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 04/22/2024Open, Classified |
| Z-1922-2024 Class II | 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | 04/22/2024Open, Classified |
| Z-1606-2024 Class II | Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang…Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas. | 03/15/2024Open, Classified |
| Z-1370-2024 Class II | SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical…Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and… | 02/21/2024Open, Classified |
| Z-0260-2024 Class II | Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N…Custom surgical procedure packs contain latex gloves but are labeled as "latex free". | 09/07/2023Open, Classified |
| Z-0099-2024 Class II | Constellation Vision System, REF: 8065751150Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to… | 08/18/2023Open, Classified |
| Z-2411-2023 Class II | Alcon Custom PakReports of patient injury during use in procedures due to potential for plastic debris from over-tightening… | 06/28/2023Open, Classified |
| Z-2410-2023 Class II | Phaco Standalone TipsReports of patient injury during use in procedures due to potential for plastic debris from over-tightening… | 06/28/2023Open, Classified |
| Z-2409-2023 Class II | Legion FMS PakReports of patient injury during use in procedures due to potential for plastic debris from over-tightening… | 06/28/2023Open, Classified |
| Z-2408-2023 Class II | Infinity FMS PakReports of patient injury during use in procedures due to potential for plastic debris from over-tightening… | 06/28/2023Open, Classified |
| Z-2407-2023 Class II | Centurion FMS PakReports of patient injury during use in procedures due to potential for plastic debris from over-tightening… | 06/28/2023Open, Classified |
| Z-2406-2023 Class II | Constellation Procedure PakReports of patient injury during use in procedures due to potential for plastic debris from over-tightening… | 06/28/2023Open, Classified |
| Z-1291-2023 Class II | Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR…Sterility; Steril surgical procedure packs contain incomplete seals. | 03/10/2023Open, Classified |
| Z-0354-2023 Class II | Alcon Custom Pak Surgical Procedure PackDue to difficulty removing the liner on the adhesive components of the affected drapes and as a result may… | 10/31/2022Open, Classified |
| Z-1373-2022 Class II | Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO…Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves. | 06/09/2022Open, Classified |
| Z-1328-2021 Class II | Alcon Custom Ophthalmic Surgical Procedure PacksReports have been received concerning mold found on gowns included in custom ophthalmic surgery packages. | 02/02/2021Terminated |
| Z-0095-2021 Class II | Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex…The third-party brand latex micro surgical gloves packaged within specific custom packs may have a… | 08/24/2020Terminated |
| Z-2287-2020 Class II | Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE…Incorrect IOL diopter | 04/17/2020Terminated |
| Z-0188-2019 Class I | CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS…Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent… | 08/28/2018Terminated |
| Z-0187-2019 Class I | CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For…Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent… | 08/28/2018Terminated |
| Z-0186-2019 Class I | CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS…Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent… | 08/28/2018Terminated |
| Z-0185-2019 Class I | CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #:…Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent… | 08/28/2018Terminated |
| Z-1794-2020 Class II | Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product…There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a… | 07/25/2018Terminated |
| Z-0779-2018 Class II | Custom Pak (Custom Pak in which Alcon 25+ TOTALPLUS Vitrectomy Pak is a component.)…Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS… | 01/12/2018Terminated |
| Z-0778-2018 Class II | Alcon 25+ TOT ALPLUS Vitrectomv Pak Includes all necessary items for a core vitrectomy…Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS… | 01/12/2018Terminated |
| Z-0053-2018 Class II | Alcon Custom PakAlcon is initiating a medical device recall, after receiving notification from a supplier of a recall for… | 08/08/2017Terminated |
| Z-3050-2017 Class II | ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens…Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This… | 06/30/2017Terminated |
| Z-3049-2017 Class II | ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular…Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This… | 06/30/2017Terminated |
| Z-3081-2017 Class II | LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic…Multiple shipments or forceful impact to a caster on a LuxOr/LX3 microscope may stress the microscope base… | 05/25/2017Terminated |
| Z-1837-2017 Class II | Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use…Alcon is initiating a Voluntary Medical Device Removal because the product supplier has stated that there is… | 03/27/2017Terminated |
| Z-0978-2017 Class II | Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof…The intraocular lens could become lodged within the cartridge | 09/05/2016Terminated |
| Z-2834-2016 Class II | LAUREATE World Phaco SystemSteps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU) | 07/28/2016Terminated |
| Z-2708-2016 Class II | Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ…The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that could result in… | 07/28/2016Terminated |
| Z-2081-2016 Class II | CENTURION Vision SystemThe grounding pin within the Power Entry Switch on certain systems was susceptible to detachment when the AC… | 05/24/2016Terminated |
| Z-1940-2016 Class II | CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and…Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS packs due… | 04/28/2016Terminated |
| Z-1688-2016 Class II | LenSx Laser System. Indicated for use in patients undergoing cataract surgery and…Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving… | 04/14/2016Terminated |
| Z-1394-2016 Class II | VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is…Alcon is conducting a voluntary medical device correction of all VERION Reference Units (Vision Planner)… | 03/01/2016Terminated |
| Z-0271-2016 Class I | Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now…Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL. | 09/29/2015Terminated |
| Z-0195-2016 Class II | Custom Pak 9319-27. Single-use medical devices and accessories designed by medical…The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified… | 09/21/2015Terminated |
| Z-2448-2015 Class II | LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product…Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands after receiving reports concerning… | 08/11/2015Terminated |
| Z-1694-2016 Class II | Custom Paks containing 23G and 25G valved trocar cannula provide access into the…The product has potential to leak beyond their design specification. | 08/11/2015Terminated |
| Z-1693-2016 Class II | 23G and 25G Constellation Totalplus Paks provides access into the posterior segment of…The product has potential to leak beyond their design specification. | 08/11/2015Terminated |
| Z-1692-2016 Class II | Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the…The product has potential to leak beyond their design specification. | 08/11/2015Terminated |
| Z-1940-2015 Class II | Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous…Insufficient seal on the outside packaging, potentially affecting the sterility of the product. | 06/02/2015Terminated |
| Z-1702-2015 Class II | The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical…The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves due to the… | 04/28/2015Terminated |
| Z-2323-2015 Class I | ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR…There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after… | 04/15/2015Terminated |
| Z-0527-2015 Class II | Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only…The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to… | 11/11/2014Terminated |
| Z-0506-2015 Class II | INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE.…Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the… | 10/30/2014Terminated |
| Z-1597-2016 Class II | INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718…The recalling firm received complaints related to leakage from the tubing near the white luer of the… | 10/06/2014Terminated |
| Z-2694-2014 Class II | eye-pak 7407 Tray Support Cover REF 8065740745The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured. | 06/03/2014Terminated |
| Z-1947-2014 Class II | Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006…Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually… | 05/16/2014Terminated |
| Z-2470-2012 Class II | This voluntary medical device correction is related to Alcon products that present a 23G…This medical device correction is related to Alcon products that present a 23G non-valved trocar cannula and… | 05/29/2012Terminated |
| Z-1461-2008 | Alcon/Grieshaber Morris ILM Forceps, Direct Action; Manual ophthalmic surgical…Device corrosion: Forceps are prone to corrosion and possibly premature fracture and/or malfunction. | 03/07/2008Terminated |
| Z-1197-2007 | Atkinson Retrobulbar Anesthesia Needles, 25 gauge 1 1/2". Catalog Number 8065420920. The…Mislabeled: boxes actually contained Tri-Fact needles | 07/11/2007Terminated |
| Z-0610-2007 | 19 Gauge Trocar Cannula Replacement Plug, Catalog Number 617.32; Manufactured by Alcon…Product is misbranded; 19 gauge Schlera Plugs distributed in containers labeled as 19 gauge Trochar Canula… | 01/18/2007Terminated |