Panels › Ophthalmic › Product code HQC · Class 2
Unit, Phacofragmentation
Regulation 886.4670
4510(k)s in 12 months (317 all time)
0recalls in 12 months (74 all time)
61recalls that name a 510(k)
Top companies in HQC
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| 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 |
| 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 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 |
| May 2, 2024 | Johnson & Johnson Surgical Vision, Inc. Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L
The irrigation sleeve is a device intended to direct irrigation solution across the shaf Open, Classified |
HQC | K121721 |
| Mar 21, 2024 | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm) Open, Classified |
HQC | K213467 |
| Mar 21, 2024 | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm) Open, Classified |
HQC | K213467 |
| Mar 21, 2024 | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm) Open, Classified |
HQC | K213467 |
| Oct 11, 2023 | Alcon Research, LLC Constellation Vision System, REF: 8065751150 Open, Classified |
HQC | K101285 K141065 |
| Aug 16, 2023 | Alcon Research, LTD. Alcon Custom Pak Open, Classified |
HQC | None listed |
| Aug 16, 2023 | Alcon Research, LTD. Phaco Standalone Tips Open, Classified |
HQC | K121555 |
| Aug 16, 2023 | Alcon Research, LTD. Legion FMS Pak Open, Classified |
HQC | K191650 |
| Aug 16, 2023 | Alcon Research, LTD. Infinity FMS Pak Open, Classified |
HQC | K021566 |
| Aug 16, 2023 | Alcon Research, LTD. Centurion FMS Pak Open, Classified |
HQC | K121555 |
| Aug 16, 2023 | Alcon Research, LTD. Constellation Procedure Pak Open, Classified |
HQC | K141065 |
| Jul 28, 2023 | Johnson & Johnson Surgical Vision, Inc. VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF) Open, Classified |
HQC | K203060 |
| Jan 20, 2023 | Johnson & Johnson Surgical Vision, Inc. Single-Use Packs, REF: OPO80 Open, Classified |
HQC | K133115 |
| Jan 20, 2023 | Johnson & Johnson Surgical Vision, Inc. FUSION Dual Pump Packs, REF: OPO73 Open, Classified |
HQC | K160236 |
| Jan 20, 2023 | Johnson & Johnson Surgical Vision, Inc. Veritas Advanced Infusion Packs, REF: VRT-AI Open, Classified |
HQC | K203060 |
| Oct 12, 2022 | Johnson & Johnson Surgical Vision, Inc. Veritas Advanced Infusion Packs. Used in ophthalmic procedures. Open, Classified |
HQC | K203060 |
| Apr 6, 2022 | Johnson & Johnson Surgical Vision Inc TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only, Open, Classified |
HQC | K951462 |
| May 21, 2019 | Dutch Ophthalmic USA, Inc. The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201. Open, Classified |
HQC | K190875 |
| Jul 25, 2018 | Alcon Research LLC Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX. Terminated |
HQC | K101285 |
| Jan 12, 2018 | Alcon Research, LTD. Custom Pak (Custom Pak in which Alcon 25+ TOTALPLUS Vitrectomy Pak is a component.)
Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System. Terminated |
HQC | K101285 |
| Jan 12, 2018 | Alcon Research, LTD. Alcon 25+ TOT ALPLUS Vitrectomv Pak
Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System. Terminated |
HQC | K101285 |
| Sep 15, 2016 | Alcon Research, Ltd. LAUREATE World Phaco System Terminated |
HQC | K021566 |
| Jun 28, 2016 | Alcon Research, Ltd. CENTURION Vision System Terminated |
HQC | K121555 |
| Jun 9, 2016 | Alcon Research, Ltd. CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks Terminated |
HQC | K121555 |
| May 3, 2016 | Alcon Research, Ltd. INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723.
An ophthalmic microsurgical system indicated for phacoemulsification and removal of c Terminated |
HQC | K021566 |
| Jun 29, 2015 | Alcon Research, Ltd. 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 wit Terminated |
HQC | K911808 |
| Dec 4, 2014 | Alcon Research, Ltd. INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE. Model Numbers: 8065741080, 8065741081, 8065741082, 8065741083,
8065741085, 8065741087, 8065741088, 8065741089, 8 Terminated |
HQC | K120912 |
| Jul 9, 2013 | Abbott Medical Optics, Inc. Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery. Terminated |
HQC | K111446 |
| Dec 20, 2012 | Bausch & Lomb Inc Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, anterior, and posterior segment vitrectom Terminated |
HQC | K101325 |
| Aug 30, 2011 | Bausch & Lomb Inc Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Needle, Ref: BL5114, packaged 6 units/case, RX, Sterile.
Bausch & Lomb Incorporated,
Rochester, NY
For use with the Bausch & Lomb Terminated |
HQC | K082473 |
| Aug 30, 2011 | Bausch & Lomb Inc Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112, packaged 6 units/case, RX, Sterile.
Bausch & Lomb Incorporated,
Rochester, NY
For use with the Bausch & Lomb Stellaris Vision Terminated |
HQC | K082473 |
| Aug 30, 2011 | Bausch & Lomb Inc Bausch & Lomb Stellaris Basic Vacuum Phaco Pack, Ref: BL5111,
packaged 6 units/case, RX, Sterile.
Bausch & Lomb Incorporated,
Rochester, NY
For use with the Bausch & Lomb Stellaris Vision Enhance Terminated |
HQC | K082473 |
| Aug 30, 2011 | Bausch & Lomb Inc Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Ref: BL5110, packaged 6 units/case, RX, Sterile.
Bausch & Lomb Incorporated,
Rochester, NY
For use with the Bausch & Lomb Stellaris Vision Enhanc Terminated |
HQC | K082473 |
| Jul 13, 2010 | Alcon Research LTD dba Alcon Laboratories, Inc. Constellation Vision System, Model: Constellation T, Catalogue Number: 8065751558
The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i. Terminated |
HQC | K063583 |
| Jul 13, 2010 | Alcon Research LTD dba Alcon Laboratories, Inc. Constellation Vision System, Model: Constellation L, Catalogue Number: 8065751554
The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i. Terminated |
HQC | K063583 |
| Jul 13, 2010 | Alcon Research LTD dba Alcon Laboratories, Inc. Constellation Vision System, Model: Constellation X, Catalogue Number: 8065751553
The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i. Terminated |
HQC | K063583 |
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