Company ยท US
Alcon Research LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2019. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
111recalls (2 in 12 months)
43recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HQC | Unit, Phacofragmentation | 34 |
| HNN | Knife, Ophthalmic | 28 |
| LRO | General Surgery Tray | 16 |
| NGY | Cannula, Trocar, Ophthalmic | 6 |
| HQL | Intraocular Lens | 4 |
| MLZ | Vitrectomy, Instrument Cutter | 4 |
| OGO | Intraocular Pressure Lowering Implant | 4 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 3 |
| NCF | Aberrometer, Ophthalmic | 3 |
| GEX | Powered Laser Surgical Instrument | 2 |
| HQB | Photocoagulator And Accessories | 2 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 2 |
| HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | 2 |
| KYB | Lens, Guide, Intraocular | 2 |
| LPL | Lenses, Soft Contact, Daily Wear | 2 |
| LPN | Accessories, Soft Lens Products | 2 |
| FWJ | Camera, Cine, Microsurgical, Without Audio | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| HMT | Drape, Patient, Ophthalmic | 1 |
| HMX | Cannula, Ophthalmic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 1, 2019 | K191650 | LEGION System Alcon Research, LLC | HQC |
| Apr 14, 2017 | K161794 | CENTURION Vision System (Active SentryTM) Alcon Research, Ltd. | HQC |
| Mar 22, 2017 | K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ Alcon Research, Ltd. | MLZ |
| Aug 22, 2014 | K141065 | CONSTELLATION VISION SYSTEM Alcon Research, Ltd. | HQE |
| Jun 21, 2012 | K121031 | WAVELIGHT FS200 PATIENT INTERFACE 1505 Alcon Research, Ltd. | GEX |
| Mar 27, 2012 | K112977 | MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) Alcon Research, Ltd. | MSS |
| Oct 17, 2011 | K110951 | 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA Alcon Research, Ltd. | HQB |
| May 20, 2011 | K110166 | CLEARCUT S SAFETY KNIFE Alcon Research, Ltd. | HNN |
| May 10, 2011 | K102860 | ALCON MULTI-PIRPOSE DISINFECTING SOLUTION Alcon Research, Ltd. | LPN |
| Oct 21, 2010 | K101006 | WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 Alcon Research, Ltd. | GEX |
| Apr 2, 2010 | K093305 | ENHANCED ULTRA VIT PROBE Alcon Research, Ltd. | MLZ |
| Oct 20, 2009 | K091777 | ALCON ULTRACHOPPER Alcon Research, Ltd. | HQC |
| Feb 12, 2009 | K082845 | INFINITI VISION SYSTEM WITH OZIL IP Alcon Research, Ltd. | HQC |
| Nov 8, 2006 | K062930 | LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM Alcon Research, Ltd. | NCF |
| Sep 14, 2005 | K050729 | ALCON MULTI-PURPOSE DISINFECTING SOLUTION Alcon Research, Ltd. | LPN |
| Jan 5, 2001 | K003768 | MONARCH II IOL DELIVERY SYSTEM Alcon Research, Ltd. | MSS |
| Jun 27, 2000 | K001157 | MONARCH II IOL DELIVERY SYSTEM Alcon Research, Ltd. | KYB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2025 | Alcon Research LLC Brand Name: Alcon Laboratories, Inc.
Product Name: Custom Pak
Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10
Software Version: N/A
Product Description: Alcon Custom Open, Classified |
LRO | None listed |
| Nov 21, 2025 | Alcon Research LLC CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF:
25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093;
25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095;
27+ TOTALPLUS CP PAK Open, Classified |
HQB | K110951 |
| Oct 24, 2025 | Alcon Research LLC Alcon PRECISION1 One-Day Contact Lenses, -2.25D. Open, Classified |
LPL | K182902 |
| Oct 24, 2025 | Alcon Research LLC Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065000356 27 Open, Classified |
NGY | None listed |
| Oct 24, 2025 | Alcon Research LLC Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065000252 UN Open, Classified |
MPA | None listed |
| Oct 24, 2025 | Alcon Research LLC Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065000393 UN Open, Classified |
HQE | None listed |
| Oct 24, 2025 | Alcon Research LLC Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065750918 PA Open, Classified |
HQC | K141065 K233876 +1 |
| Oct 24, 2025 | Alcon Research LLC Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065000250 UN Open, Classified |
MLZ | K141065 K233876 +1 |
| Jul 10, 2025 | Alcon Research LLC Brand Name: Alcon Laboratories, Inc.
Product Name: Custom Pak
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
Software Version: N/A
Product Description: Alcon Custom Paks are c Open, Classified |
LRO | None listed |
| Jul 10, 2025 | Alcon Research LLC Brand Name: Alcon Laboratories, Inc.
Product Name: Constellation Vision System Combined Procedure Pak
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
Software Version: N/A
Prod Open, Classified |
HQC | K141065 |
| Jul 10, 2025 | Alcon Research LLC Brand Name: Alcon Laboratories, Inc.
Product Name: Constellation Vision System Vitrectomy Procedure Pak
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
Software Version: N/A
Pr Open, Classified |
MLZ | K141065 |
| Mar 6, 2025 | Alcon Research LLC Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-1 Open, Classified |
LRO | K880961 |
| Jan 10, 2025 | Alcon Research LLC Brand Name: Alcon
Product Name: Monarch III D Delivery Cartridge
Model/Catalog Number: 8065977763
Product Description: Monarch III D delivery cartridge
Lens Guide, Intraocular
Component: N/A Open, Classified |
KYB | K063155 |
| Nov 19, 2024 | Alcon Research LLC a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR;
b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557- Open, Classified |
OJK | None listed |
| Sep 30, 2024 | Alcon Research LLC DAILIES TOTAL1,
DAILIES TOTAL1 for Astigmatism,
DAILIES TOTAL1 Multifocal,
TOTAL30 Sphere, Open, Classified |
LPL | K232921 K233856 |
| Aug 16, 2024 | Alcon Research LLC Product Name: 25+TTLPL VPK 20000CPM BEV VAL
Model/Catalog Number: 8065753106
Software Version: N/A
Component: N/A Open, Classified |
HQC | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9
Model/Catalog Number: 8065752451
Software Version: N/A
Component: N/A Open, Classified |
HQC | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9
Model/Catalog Number: 8065752450
Software Version: N/A
Component: N/A Open, Classified |
HQC | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Name: TOTAL PLUS,25+,10K VALVE WD
Model/Catalog Number: 8065752438
Software Version: N/A
Component: N/A Open, Classified |
HQC | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Name: TOTAL PLUS,25+,10K VALVE STD
Model/Catalog Number: 8065752437
Software Version: N/A
Component: N/A Open, Classified |
HQC | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9
Model/Catalog Number: 8065751767
Software Version: N/A
Component: N/A Open, Classified |
HQC | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6
Model/Catalog Number: 8065751618
Software Version: N/A
Component: N/A Open, Classified |
HQC | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Name: TOTAL PLUS,25+ 7.5CPM VALVE
Model/Catalog Number: 8065751617
Software Version: N/A
Component: N/A Open, Classified |
HQC | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU
Model/Catalog Number: 8065000093
Software Version: N/A
Component: N/A Open, Classified |
HQC | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU
Model/Catalog Number: 8065000095
Software Version: N/A
Component: N/A Open, Classified |
HQC | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL
Model/Catalog Number: 8065993047
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG
Model/Catalog Number: 8065993045
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG
Model/Catalog Number: 8065992761
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA
Model/Catalog Number: 8065992747
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN
Model/Catalog Number: 8065992745
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL
Model/Catalog Number: 8065992647
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG
Model/Catalog Number: 8065992561
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG
Model/Catalog Number: 8065992445
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG
Model/Catalog Number: 8065992245
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG
Model/Catalog Number: 8065990002
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE
Model/Catalog Number: 8065983265
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE
Model/Catalog Number: 8065983065
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled
Model/Catalog Number: 8065982465
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled
Model/Catalog Number: 8065921541
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: 20 Gauge V-Lance Knife
Model/Catalog Number: 8065912001
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN
Model/Catalog Number: 8065911901
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG
Model/Catalog Number: 8065772745
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4
Model/Catalog Number: 8065772465
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4
Model/Catalog Number: 8065772445
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2
Model/Catalog Number: 8065772265
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2
Model/Catalog Number: 8065772245
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel
Model/Catalog Number: 8065771541
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A Open, Classified |
HNN | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Name: Alcon Custom Pak
Model/Catalog Number: Many
Software Version: N/A
Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intende Open, Classified |
LRO | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Name: 25+ TTL PLUS VPAK 20000CPM BWV
Model/Catalog Number: 8065830077
Software Version: N/A
Product Description: Standardized assemblage of components, which includes the valved trocar entry s Open, Classified |
HQC | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Name: 25GA VALVED ENTRY SYSTEM,3CT
Model/Catalog Number: 8065751658
Software Version: N/A
Product Description: Valved Trocar Entry System
Component: N/A Open, Classified |
HQC | None listed |
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