ClearanceBrief
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)
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Top companies in HQC

DateFirm and productCodeLinked 510(k)
Oct 24, 2025Alcon 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
HQCK141065
K233876 +1
Jul 10, 2025Alcon 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
HQCK141065
Aug 16, 2024Alcon Research LLC
Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A
Open, Classified
HQCNone listed
Aug 16, 2024Alcon 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
HQCNone listed
Aug 16, 2024Alcon 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
HQCNone listed
Aug 16, 2024Alcon Research LLC
Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/A
Open, Classified
HQCNone listed
Aug 16, 2024Alcon Research LLC
Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software Version: N/A Component: N/A
Open, Classified
HQCNone listed
Aug 16, 2024Alcon 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
HQCNone listed
Aug 16, 2024Alcon Research LLC
Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software Version: N/A Component: N/A
Open, Classified
HQCNone listed
Aug 16, 2024Alcon Research LLC
Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software Version: N/A Component: N/A
Open, Classified
HQCNone listed
Aug 16, 2024Alcon 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
HQCNone listed
Aug 16, 2024Alcon 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
HQCNone listed
Aug 16, 2024Alcon 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
HQCNone listed
Aug 16, 2024Alcon 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
HQCNone listed
May 2, 2024Johnson & 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
HQCK121721
Mar 21, 2024D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
Open, Classified
HQCK213467
Mar 21, 2024D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
Open, Classified
HQCK213467
Mar 21, 2024D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)
Open, Classified
HQCK213467
Oct 11, 2023Alcon Research, LLC
Constellation Vision System, REF: 8065751150
Open, Classified
HQCK101285
K141065
Aug 16, 2023Alcon Research, LTD.
Alcon Custom Pak
Open, Classified
HQCNone listed
Aug 16, 2023Alcon Research, LTD.
Phaco Standalone Tips
Open, Classified
HQCK121555
Aug 16, 2023Alcon Research, LTD.
Legion FMS Pak
Open, Classified
HQCK191650
Aug 16, 2023Alcon Research, LTD.
Infinity FMS Pak
Open, Classified
HQCK021566
Aug 16, 2023Alcon Research, LTD.
Centurion FMS Pak
Open, Classified
HQCK121555
Aug 16, 2023Alcon Research, LTD.
Constellation Procedure Pak
Open, Classified
HQCK141065
Jul 28, 2023Johnson & Johnson Surgical Vision, Inc.
VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
Open, Classified
HQCK203060
Jan 20, 2023Johnson & Johnson Surgical Vision, Inc.
Single-Use Packs, REF: OPO80
Open, Classified
HQCK133115
Jan 20, 2023Johnson & Johnson Surgical Vision, Inc.
FUSION Dual Pump Packs, REF: OPO73
Open, Classified
HQCK160236
Jan 20, 2023Johnson & Johnson Surgical Vision, Inc.
Veritas Advanced Infusion Packs, REF: VRT-AI
Open, Classified
HQCK203060
Oct 12, 2022Johnson & Johnson Surgical Vision, Inc.
Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
Open, Classified
HQCK203060
Apr 6, 2022Johnson & Johnson Surgical Vision Inc
TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
Open, Classified
HQCK951462
May 21, 2019Dutch 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
HQCK190875
Jul 25, 2018Alcon 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
HQCK101285
Jan 12, 2018Alcon 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
HQCK101285
Jan 12, 2018Alcon 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
HQCK101285
Sep 15, 2016Alcon Research, Ltd.
LAUREATE World Phaco System
Terminated
HQCK021566
Jun 28, 2016Alcon Research, Ltd.
CENTURION Vision System
Terminated
HQCK121555
Jun 9, 2016Alcon Research, Ltd.
CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
Terminated
HQCK121555
May 3, 2016Alcon 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
HQCK021566
Jun 29, 2015Alcon 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
HQCK911808
Dec 4, 2014Alcon 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
HQCK120912
Jul 9, 2013Abbott Medical Optics, Inc.
Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Terminated
HQCK111446
Dec 20, 2012Bausch & 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
HQCK101325
Aug 30, 2011Bausch & 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
HQCK082473
Aug 30, 2011Bausch & 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
HQCK082473
Aug 30, 2011Bausch & 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
HQCK082473
Aug 30, 2011Bausch & 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
HQCK082473
Jul 13, 2010Alcon 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
HQCK063583
Jul 13, 2010Alcon 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
HQCK063583
Jul 13, 2010Alcon 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
HQCK063583

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