Atlas FDA

HQC

316 FDA 510(k) clearances · Product code

88 daysmedian time to decision
240 days90th percentile
316clearances measured

FDA profile

Official device name
Unit, Phacofragmentation
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4670
Medical specialty
Ophthalmic
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 1,673 · 2022: 1,907 · 2023: 1,799 · 2024: 2,185 · 2025: 1,941 · 2026: 1,202
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+ (K261264)Bausch and Lomb2026-05-15
Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) (K252052)Bausch and Lomb, Incorporated2026-03-25
System Sophi (K250501)This AG2025-11-14
MICOR 700 with Auto I/A (K243395)Carl Zeiss Meditec Cataract Technology, Inc.2025-08-08
MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) (K242801)Carl Zeiss Meditec Cataract Technology, Inc.2025-06-11
Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) (K240169)Bausch and Lomb, Incorporated2024-07-26
Faros Surgical System (K233398)Oertli Instrumente AG2024-06-27
UNITY VCS (8065000296); UNITY CS (8065000297) (K233876)Alcon Laboratories, Inc.2024-06-21
Stellaris Elite vision enhancement system (K232084)Bausch and Lomb2024-02-26
Centurion™ Vision System (Active Sentry™) (8065753057) (K233902)Alcon Laboratories, Inc.2024-01-10
QUATERA 700 (K230858)Carl Zeiss Meditec, AG2023-07-31
MICOR Lens Fragmentation System (K214028)Carl Zeiss Meditec Cataract Technology, Inc.2022-09-09
miCOR System Lens Fragmentation System (K222236)Carl Zeiss Meditec Cataract Technology, Inc.2022-08-24
EVA NEXUS Ophthalmic Surgical System (K213467)D.O.R.C. Dutch Ophthalmic Research Center (International)2022-06-14
QUATERA 700 (K212241)Carl Zeiss Meditec, AG2022-04-19
VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control (K203060)Johnson & Johnson Surgical Vision, Inc.2021-03-12
xPORT S Lens Fragmentation System (K200207)Carl Zeiss Meditec Cataract Technology, Inc.2020-10-15
xPORT 304 (miCOR) System Lens Fragmentation System (K200584)Carl Zeiss Meditec Cataract Technology, Inc.2020-07-31
Visalis V500, Visalis S500 (K193376)Carl Zeiss Meditec, AG2020-06-15
Phacoemulsification Needle (Tip) and Irrigation Sleeve (K192418)Raico, LLC2020-05-27
LEGION System (K191650)Alcon Research, LLC2019-11-01
EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) (K190875)D.O.R.C. Dutch Ophthalmic Research Center (International)2019-09-25
COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal (K191933)Johnson & Johnson Surgical Vision, Inc.2019-08-16
xPORT Lens Fragmentation System (K191024)Carl Zeiss Meditec Cataract Technology, Inc.2019-08-13
Stellaris Elite vision enhancement system (K170052)Bausch+Lomb2017-04-19
CENTURION Vision System (Active SentryTM) (K161794)Alcon Research, Ltd.2017-04-14
Stellaris Elite Vision Enhancement System (K162342)Bausch+Lomb2017-03-24
Dual Pump Pack (K160236)Abbott Medical Optics, Inc.2016-04-27
AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control (K151636)Abbott Medical Optics, Inc.2015-10-19
COMPACT INTUITIV Multiple-Use Pack (K151783)Abbott Medical Optics, Inc.2015-09-02
EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector) (K142877)Dutch Ophthalmic Research Center International BV2015-03-13
CATARHEX 3 (K133562)Oertli Instrumente AG2014-08-12
STELLARIS PC VISION ENHANCEMENT SYSTEM (K133486)Bausch & Lomb2014-03-12
COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK (K133115)Abbott Medical Optics, Inc.2014-02-27
STELLARIS VISION ENHANCEMENT SYSTEM (K133242)Bausch & Lomb2014-02-14
CENTURION VISION SYSTEM (K121555)Alcon Laboratories, Inc.2012-12-21
LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS (K122829)Lensar, Inc.2012-12-03
LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) (K121721)Abbott Medical Optics, Inc.2012-10-15
LENSSX LASER SYSTEM (K120732)Alcon Lensx, Inc.2012-09-06
INFINITI(R) VISION SYSTEM (K120912)Alcon Manufacturing, Ltd.2012-06-15
SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM (K111446)Abbott Medical Optics, Inc.2011-12-21
INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE (K112425)Alcon Manufacturing, Ltd.2011-11-21
LAMINAR FLOW PHACO TIPS (K111882)Abbott Medical Optics, Inc.2011-11-07
AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM (K111697)Abbott Medical Optics, Inc.2011-09-27
UNIT, PHACOFRAGMENTATION (K103023)Abbott Medical Optics, Inc.2011-06-01
CONSTELLATION VISION SYSTEM (K101285)Alcon Manufacturing, Ltd.2010-11-12
STELLARIS PC VISION ENHANCEMENT SYSTEM (K101325)Bausch & Lomb, Inc.2010-08-17
AQUALASE CAPSULE WASH TIP (K093210)Alcon Manufacturing, Ltd.2010-03-04
FLUID ISOLATION DEVICE (K091915)Lenstec, Inc.2009-10-27
ALCON ULTRACHOPPER (K091777)Alcon Research, Ltd.2009-10-20
INFINITI VISION SYSTEM WITH OZIL IP (K082845)Alcon Research, Ltd.2009-02-12
BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM (K082473)Bausch & Lomb, Inc.2009-01-05
ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS (K081877)Dutch Ophthalmic Research Center International BV2009-01-05
VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551 (K080803)American Optisurgical, Inc.2008-09-22
BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK (K082132)Bausch & Lomb, Inc.2008-08-28
ALCON VISION SYSTEM (K063583)Alcon2008-05-09
STERILS SINGLE-USE I/A HANDPIECES (K073023)Bausch & Lomb, Inc.2008-03-12
BAUSCH & LOMB NGX MICROSURGICAL SYSTEM (K063331)Bausch & Lomb, Inc.2006-12-19
THE AMO OPHTHALMIC SURGICAL SYSTEM (K060366)Advanced Medical Optics, Inc.2006-04-07
MICROPULSE PHACOEMULSIFICATION SYSTEM (K051186)Trillium Medical, Inc.2005-08-18
SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK (K050648)Advanced Medical Optics, Inc.2005-04-05
PHACO CHOP NEEDLES (K041998)Bausch & Lomb, Inc.2004-08-16
VENTURI PHACO PACK (K033653)Bausch & Lomb, Inc.2003-12-17
PERFECT CAPSULE (K030957)Milvella Pty. , Ltd.2003-08-20
DIGNITY OPHTHALMIC SURGICAL SYSTEM (K031404)Phacor Inc., A Santen Company2003-05-22
BENJAMIN ENVOY PHACO HANDPIECE (K022833)Benjamin Biomedical, Inc.2002-09-09
HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030 (K020527)American Optisurgical, Inc.2002-07-09
INFINITI (K021566)Alcon Laboratories, Inc.2002-07-02
SURGE-FREE ASPIRATION ADAPTER (K020734)Staar Surgical Co.2002-05-16
MOJAVE CATARACT EXTRACTION SYSTEM (K003638)Allergan, Inc.2001-02-13
LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II (K003512)A.R.C. Laser AG2001-02-08
PHACOGARD (K002932)Syntec, Inc.2001-01-04
PHACOFRAGMENTATION SYSTEM MEGATRON (K002031)Asclepion-Meditec AG2000-12-27
A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 (K002986)A.R.C. Laser AG2000-11-29
IRIS RETRACTING PHACOEMULSIFICATION SLEEVE (K002812)Michael Reynard, M.D.2000-11-08
OCUSYSTEM ART ADVANTAGE, MODEL 995 (K991852)Surgical Design Corp.1999-07-07
FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM (K984143)Fibra Sonics, Inc.1999-02-16
THE WAVE DIGITAL PHACO SYSTEM (K981989)Circuit Tree1998-08-25
TURBOSONICS LIMITED REUSE ULTRASONIC TIP (K981103)Alcon Laboratories1998-06-23
QUITETIP (K981109)Paradigm Medical Industries, Inc.1998-06-09
SYNTEC VITMAN (K980480)Syntec, Inc.1998-05-04
PHACO COMMANDER (K980085)Scieran Technologies, Inc.1998-02-24
MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL (K974469)Mentor Corp.1998-02-24
PHACOPAK (K974719)Paradigm Medical Industries, Inc.1998-01-20
FRAG COMMANDER (K973749)Scieran Technologies, Inc.1997-12-08
WHITTINGHAM ULTRACLEAN PHACO HANDPIECE (K972063)William F. Whittingham1997-11-25
VISTA UNIVERSAL HANDPIECE (K972252)Odyssey Technologies, Inc.1997-07-29
P3 UNIVERSAL PHACO HANDPIECE (K972253)Odyssey Technologies, Inc.1997-07-29
AUTOMATED CHAMBER MAINTENANCE MODULE (K971795)Paradigm Medical Industries, Inc.1997-07-14
WELCH ALLYN PHACO ILLUMINATOR (K971750)Welch Allyn, Inc.1997-06-30
STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES (K971439)Storz Instrument Co.1997-06-17
AMO DIPLOMAX/OPSYS CONSOLE (K971186)Allergan, Inc.1997-06-13
BAYERS BIMANUAL I/A HANDPIECES (K971064)Visioncare Devices, Inc.1997-06-09
DGH MODEL 9000 (K965127)Dgh Technology, Inc.1997-03-17
PHACOILLUMINATOR - FIBEROPTIC SLEEVE (K964018)Michael Reynard, M.D.1997-02-26
HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM (K960287)Nidek, Inc.1996-11-05
PHACOSCOPE (K960811)Saint John'S Plaza Medical Group1996-10-02
STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH (K960024)Storz Instrument Co.1996-09-20
AMO PRESTIGE DAY PACK (ALLERGAN, INC.) (K962402)Allergan, Inc.1996-09-19
STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION (K960003)Storz Instrument Co.1996-08-29
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