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

Company510(k)sRecalls
Alcon Research, LLC430
Bausch & Lomb1118
Storz Instrument Co.170
Chiron Vision Corp.150
CooperVision, Inc.150
Site Microsurgical Systems, Inc.140
Alcon Research LTD dba Alcon Laboratories, Inc.011
Abbott Medical Optics, Inc.91
Johnson & Johnson Surgical Vision, Inc.27
Alcon Laboratories80
Decided510(k)Device and applicantCode
Oct 15, 2026K262097MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621)
Carl Zeiss Meditec Cataract Technologies
HQC
May 15, 2026K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE54
Bausch and Lomb
HQC
Mar 25, 2026K252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)
Bausch and Lomb, Incorporated
HQC
Nov 14, 2025K250501System Sophi
This AG, CH
HQC
Aug 8, 2025K243395MICOR 700 with Auto I/A
Carl Zeiss Meditec Cataract Technology, Inc.
HQC
Jun 11, 2025K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)
Carl Zeiss Meditec Cataract Technology, Inc.
HQC
Jul 26, 2024K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
Bausch and Lomb, Incorporated
HQC
Jun 27, 2024K233398Faros Surgical System
Oertli Instrumente AG, CH
HQC
Jun 21, 2024K233876UNITY VCS (8065000296); UNITY CS (8065000297)
Alcon Laboratories, Inc.
HQC
Feb 26, 2024K232084Stellaris Elite vision enhancement system
Bausch and Lomb
HQC
Jan 10, 2024K233902Centurion™ Vision System (Active Sentry™) (8065753057)
Alcon Laboratories, Inc.
HQC
Jul 31, 2023K230858QUATERA 700
Carl Zeiss Meditec, AG, DE
HQC
Sep 9, 2022K214028MICOR Lens Fragmentation System
Carl Zeiss Meditec Cataract Technology, Inc.
HQC
Aug 24, 2022K222236miCOR System Lens Fragmentation System
Carl Zeiss Meditec Cataract Technology, Inc.
HQC
Jun 14, 2022K213467EVA NEXUS Ophthalmic Surgical System
D.O.R.C. Dutch Ophthalmic Research Center (International), NL
HQC
Apr 19, 2022K212241QUATERA 700
Carl Zeiss Meditec, AG, DE
HQC
Mar 12, 2021K203060VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece
Johnson & Johnson Surgical Vision, Inc.
HQC
Oct 15, 2020K200207xPORT S Lens Fragmentation System
Carl Zeiss Meditec Cataract Technology, Inc.
HQC
Jul 31, 2020K200584xPORT 304 (miCOR) System Lens Fragmentation System
Carl Zeiss Meditec Cataract Technology, Inc.
HQC
Jun 15, 2020K193376Visalis V500, Visalis S500
Carl Zeiss Meditec, AG, DE
HQC
May 27, 2020K192418Phacoemulsification Needle (Tip) and Irrigation Sleeve
Raico, LLC
HQC
Nov 1, 2019K191650LEGION System
Alcon Research, LLC
HQC
Sep 25, 2019K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine wit
D.O.R.C. Dutch Ophthalmic Research Center (International), NL
HQC
Aug 16, 2019K191933COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTU
Johnson & Johnson Surgical Vision, Inc.
HQC
Aug 13, 2019K191024xPORT Lens Fragmentation System
Carl Zeiss Meditec Cataract Technology, Inc.
HQC
Apr 19, 2017K170052Stellaris Elite vision enhancement system
Bausch+Lomb
HQC
Apr 14, 2017K161794CENTURION Vision System (Active SentryTM)
Alcon Research, Ltd.
HQC
Mar 24, 2017K162342Stellaris Elite Vision Enhancement System
Bausch+Lomb
HQC
Apr 27, 2016K160236Dual Pump Pack
Abbott Medical Optics, Inc.
HQC
Oct 19, 2015K151636AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal,
Abbott Medical Optics, Inc.
HQC
Sep 2, 2015K151783COMPACT INTUITIV Multiple-Use Pack
Abbott Medical Optics, Inc.
HQC
Mar 13, 2015K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with
Dutch Ophthalmic Research Center International BV, NL
HQC
Aug 12, 2014K133562CATARHEX 3
Oertli Instrumente AG, CH
HQC
Mar 12, 2014K133486STELLARIS PC VISION ENHANCEMENT SYSTEM
Bausch & Lomb
HQC
Feb 27, 2014K133115COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK
Abbott Medical Optics, Inc.
HQC
Feb 14, 2014K133242STELLARIS VISION ENHANCEMENT SYSTEM
Bausch & Lomb
HQC
Dec 21, 2012K121555CENTURION VISION SYSTEM
Alcon Laboratories, Inc.
HQC
Dec 3, 2012K122829LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS
Lensar, Inc.
HQC
Oct 15, 2012K121721LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)
Abbott Medical Optics, Inc.
HQC
Sep 6, 2012K120732LENSSX LASER SYSTEM
Alcon Lensx, Inc.
HQC
Jun 15, 2012K120912INFINITI(R) VISION SYSTEM
Alcon Manufacturing, Ltd.
HQC
Dec 21, 2011K111446SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM
Abbott Medical Optics, Inc.
HQC
Nov 21, 2011K112425INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE
Alcon Manufacturing, Ltd.
HQC
Nov 7, 2011K111882LAMINAR FLOW PHACO TIPS
Abbott Medical Optics, Inc.
HQC
Sep 27, 2011K111697AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM
Abbott Medical Optics, Inc.
HQC
Jun 1, 2011K103023UNIT, PHACOFRAGMENTATION
Abbott Medical Optics, Inc.
HQC
Nov 12, 2010K101285CONSTELLATION VISION SYSTEM
Alcon Manufacturing, Ltd.
HQC
Aug 17, 2010K101325STELLARIS PC VISION ENHANCEMENT SYSTEM
Bausch & Lomb, Inc.
HQC
Mar 4, 2010K093210AQUALASE CAPSULE WASH TIP
Alcon Manufacturing, Ltd.
HQC
Oct 27, 2009K091915FLUID ISOLATION DEVICE
Lenstec, Inc.
HQC

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