Chrysalis Intelligence · Sponsors · Alcon Laboratories, Inc.

Alcon Laboratories, Inc.

Fort Worth, TX, US · 16 510(k) clearances · 167 PMAs

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Total clearances
16
2020-08-21 → 2026-02-13
Last 12 months
2
Product codes
6
Most recent
2026-02-13
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LPL Lenses, Soft Contact, Daily Wear Class II Ophthalmic 8 2026-02-13
OOE Ophthalmic Femtosecond Laser Class II Ophthalmic 2 2025-09-24
HQC — — — 2 2024-06-21
MVN Lens, Contact, (Disposable) Class II Ophthalmic 2 2020-09-22
MPA Endoilluminator Class II Gastroenterology, Urology 1 2024-12-04
MSS — — — 1 2021-08-23
Class III

PMA approvals (167)

Total PMA records
167
Originals + supplements
Distinct product codes
7
First decision
2020-01-07
Most recent
2026-08-04
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-08-04 P840064-S092 VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System. Normal 180 Day Track No User Fee LZP — —
2026-07-08 P930014-S164 AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems 30-Day Notice HQL Intraocular Lens Ophthalmic
2026-07-06 P930014-S163 Acrosof Posterior Chamber Intraocular Lens 30-Day Notice HQL Intraocular Lens Ophthalmic
2026-07-06 P190018-S053 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens 30-Day Notice HQL Intraocular Lens Ophthalmic
2026-07-02 P930014-S165 AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems 30-Day Notice HQL Intraocular Lens Ophthalmic
2026-07-02 P190018-S054 Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon® Toric Aspheric Hydrophobic Acrylic Intraocular Le 30-Day Notice HQL Intraocular Lens Ophthalmic
2026-07-02 P190018-S052 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon ToricAspheric Hydrophobic Acrylic Intraocular Lens 30-Day Notice HQL Intraocular Lens Ophthalmic
2026-05-29 P010019-S087 FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2026-05-15 P190018-S046 Clareon Vivity™ Toric Extended Vision UV Absorbing Hydrophobic Intraocular Lens (IOL) Normal 180 Day Track HQL Intraocular Lens Ophthalmic
2026-04-30 P930014-S161 AcrySof Single-Piece IOL (SA60AT); AcrySof IQ Aspheric IOL (SN60WF); AcrySof Aspheric UV-Absorbing IOL (SA60WF); AcrySof Normal 180 Day Track HQL Intraocular Lens Ophthalmic
2026-04-30 P190018-S048 Clareon Aspheric Hydrophobic Acrylic IOL (SY60WF); Clareon Aspheric UV Absorbing IOL (CC60WF); Clareon Toric Aspheric UV Normal 180 Day Track HQL Intraocular Lens Ophthalmic
2026-03-11 P220007-S007 Precision7; Precision7 for Astigmatism; Precision7 Multifocal 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2026-03-02 P930014-S162 AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems 30-Day Notice HQL Intraocular Lens Ophthalmic
2026-03-02 P190018-S049 Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon® PanOptix Hydrophobic Acrylic IOL 30-Day Notice HQL Intraocular Lens Ophthalmic
2026-02-26 P010019-S086 Air Optix Plus Hydraglyde (lotrafilcon B) Spherical and Multifocal Soft Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2026-02-19 P190018-S047 Clareon TruPlus Aspheric Hydrophobic Acrylic Intraocular Lens (IOL); Clareon TruPlus Toric Aspheric Hydrophobic Acrylic Real-Time Process HQL Intraocular Lens Ophthalmic
2026-02-11 P930014-S160 AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems 30-Day Notice HQL Intraocular Lens Ophthalmic
2026-02-10 P840064-S089 VISCOAT™ Ophthalmic Viscosurgical Device Normal 180 Day Track LZP — —
2025-12-12 P930014-S159 AcrySof Posterior Chamber Intraocular Lens and Delivery Systems 30-Day Notice HQL Intraocular Lens Ophthalmic
2025-12-12 P190018-S045 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon PanOptix Hydrophobic Acrylic IOL 30-Day Notice HQL Intraocular Lens Ophthalmic
2025-10-03 P840064-S091 VISCOAT™ Ophthalmic Viscosurgical Device; DUOVISC™ Ophthalmic Viscoelastic System; DISCOVISC™ Ophthalmic Viscosurgical D 30-Day Notice LZP — —
2025-09-18 P930014-S158 AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems 30-Day Notice HQL Intraocular Lens Ophthalmic
2025-09-18 P190018-S044 Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon® Toric Aspheric Hydrophobic Acrylic Intraocular Le 30-Day Notice HQL Intraocular Lens Ophthalmic
2025-08-25 P930014-S157 AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems 30-Day Notice HQL Intraocular Lens Ophthalmic
2025-08-25 P190018-S043 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon ToricAspheric Hydrophobic Acrylic Intraocular Lens, 30-Day Notice HQL Intraocular Lens Ophthalmic
2025-07-25 P840064-S090 VISCOAT™ Ophthalmic Viscosurgical Device, DISCOVISC™ Ophthalmic Viscosurgical Device 30-Day Notice LZP — —
2025-07-18 P190018-S042 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon ToricAspheric Hydrophobic Acrylic Intraocular Lens, 30-Day Notice HQL Intraocular Lens Ophthalmic
2025-06-18 P930014-S152 AcrySof Posterior Chamber Intraocular Lenses and Delivery Systems Normal 180 Day Track No User Fee HQL Intraocular Lens Ophthalmic
2025-06-18 P190018-S039 Clareon Aspheric Hydrophobic Acrylic Intraocular Lenses Normal 180 Day Track No User Fee HQL Intraocular Lens Ophthalmic
2025-03-21 P930014-S154 AcrySof Posterior Chamber Intraocular Lenses Normal 180 Day Track No User Fee HQL Intraocular Lens Ophthalmic
2025-03-05 P020050-S043 WaveLight EX500 Laser Panel Track LZS Excimer Laser System Unknown
2025-02-26 P840064-S088 DISCOVISC Ophthalmic Viscosurgical Device 30-Day Notice LZP — —
2025-02-14 P930014-S155 AcrySof Posterior Chamber Intraocular Lens (IOL) 30-Day Notice HQL Intraocular Lens Ophthalmic
2025-02-04 P930014-S153 AcrySof Posterior Chamber Intraocular Lens and Delivery Systems 30-Day Notice HQL Intraocular Lens Ophthalmic
2025-02-04 P190018-S040 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens 30-Day Notice HQL Intraocular Lens Ophthalmic
2025-01-16 P030008-S039 WaveLight EX500 Laser System Real-Time Process LZS Excimer Laser System Unknown
2025-01-16 P020050-S044 WaveLight EX500 Laser System Real-Time Process LZS Excimer Laser System Unknown
2025-01-06 P220007-S006 Precision7™, Precision7™ for Astigmatism, Precision7™ Multifocal, Precision7™ Multifocal Toric 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-12-16 P190018-S038 Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric UV Absorbing Intraocular Lens Real-Time Process HQL Intraocular Lens Ophthalmic
2024-09-04 P220007-S005 Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft Conta 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-08-12 P840064-S086 VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System (consists of PROVISC and VISCOAT), DIS 30-Day Notice LZP — —
2024-08-09 P930014-S151 AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems 30-Day Notice HQL Intraocular Lens Ophthalmic
2024-08-09 P190018-S037 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens 30-Day Notice HQL Intraocular Lens Ophthalmic
2024-07-12 P930014-S149 AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems 135 Review Track For 30-Day Notice HQL Intraocular Lens Ophthalmic
2024-07-12 P190018-S032 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon PanOptix Hydrophobic Acrylic IOL 135 Review Track For 30-Day Notice HQL Intraocular Lens Ophthalmic
2024-06-20 P930014-S150 AcrySof Posterior Chamber Intraocular Lens and Delivery Systems 30-Day Notice HQL Intraocular Lens Ophthalmic
2024-06-20 P880087-S033 PMMA Single-Piece Anterior Chamber IOL 30-Day Notice HQL Intraocular Lens Ophthalmic
2024-06-20 P840060-S051 PMMA Multiple and Single-Piece Posterior Chamber IOLs 30-Day Notice HQL Intraocular Lens Ophthalmic
2024-06-20 P810032-S071 PMMA Multiple and Single-Piece Posterior Chamber IOLs 30-Day Notice HQL Intraocular Lens Ophthalmic
2024-06-20 P190018-S036 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon PanOptix Hydrophobic Acrylic IOL 30-Day Notice HQL Intraocular Lens Ophthalmic
2024-06-17 P840064-S085 VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System, DISCOVISC™ Ophthalmic Viscosurgical 30-Day Notice LZP — —
2024-06-11 P950018-S028 Perfluoron 30-Day Notice LWL Fluid, Intraocular Ophthalmic
2024-06-11 P190018-S034 Clareon PanOptix Trifocal IOL 30-Day Notice HQL Intraocular Lens Ophthalmic
2024-05-31 P190018-S035 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon PanOptix Hydrophobic Acrylic IOL works 30-Day Notice HQL Intraocular Lens Ophthalmic
2024-05-29 P930014-S148 AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems 135 Review Track For 30-Day Notice HQL Intraocular Lens Ophthalmic
2024-05-29 P190018-S031 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens 135 Review Track For 30-Day Notice HQL Intraocular Lens Ophthalmic
2024-05-21 P190018-S027 Clareon Vivity™ Extended Vision Hydrophobic Intraocular Lens (IOL), Clareon Vivity™ Toric Extended Vision Hydrophobic IO Normal 180 Day Track HQL Intraocular Lens Ophthalmic
2024-05-15 P010019-S085 Lotrafilcon A and B soft Contact Lenses 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-04-17 P220007-S004 Precision7 ™, Precision7 ™ for Astigmatism, Precision7 ™ Multifocal, Precision7 ™ Multifocal Toric 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-03-27 P840064-S084 VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System, DISCOVISC™ Ophthalmic Viscosurgical 30-Day Notice LZP — —
2024-03-21 P220007-S003 Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft Conta 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-03-05 P190018-S030 Clareon PanOptix Pro Trifocal IOLs Real-Time Process HQL Intraocular Lens Ophthalmic
2024-02-15 P030008-S038 WaveLight EX500 Laser Real-Time Process LZS Excimer Laser System Unknown
2024-02-15 P020050-S042 WaveLight EX500 Laser Real-Time Process LZS Excimer Laser System Unknown
2023-12-18 P840064-S083 VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System, DISCOVISC™ Ophthalmic Viscosurgical 30-Day Notice LZP — —
2023-12-18 P190018-S029 Clareon PanOptix Pro Trifocal Intraocular Lens (IOL), Clareon PanOptix Pro Trifocal Toric IOLs, Clareon PanOptix Pro Tr Real-Time Process HQL Intraocular Lens Ophthalmic
2023-12-15 P010019-S084 Lotrafilcon B soft contact lenses for daily and extended wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2023-12-12 P950018-S027 Perfluoron 30-Day Notice LWL Fluid, Intraocular Ophthalmic
2023-11-28 P950018-S026 Perfluoron Special (Immediate Track) LWL Fluid, Intraocular Ophthalmic
2023-11-21 P950018-S025 Perfluoron 30-Day Notice LWL Fluid, Intraocular Ophthalmic
2023-10-25 P930014-S147 AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems 30-Day Notice HQL Intraocular Lens Ophthalmic
2023-10-25 P880087-S032 PMMA Single-Piece Anterior Chamber Intraocular Lens 30-Day Notice HQL Intraocular Lens Ophthalmic
2023-10-25 P840060-S050 PMMA Single-Piece Posterior Chamber Intraocular Lens 30-Day Notice HQL Intraocular Lens Ophthalmic
2023-10-24 P930014-S146 AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems 30-Day Notice HQL Intraocular Lens Ophthalmic
2023-10-24 P190018-S028 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens 30-Day Notice HQL Intraocular Lens Ophthalmic
2023-09-05 P840064-S081 VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscoelastic System, and DISCOVISC™ Ophthalmic Viscosurgic 30-Day Notice LZP — —
2023-08-31 P840064-S082 VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscoelastic System, and DISCOVISC™ Ophthalmic Viscosurgic 30-Day Notice LZP — —
2023-08-29 P950018-S024 Perfluoron 30-Day Notice LWL Fluid, Intraocular Ophthalmic
2023-08-23 P030008-S037 WaveLight EX500 Laser System Real-Time Process LZS Excimer Laser System Unknown
2023-08-23 P020050-S041 WaveLight EX500 Laser System Real-Time Process LZS Excimer Laser System Unknown
2023-08-15 P840064-S080 VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System (consists of PROVISC™ and VISCOAT™), 30-Day Notice LZP — —
2023-08-11 P220007-S002 Precision7 ™, Precision7 ™ for Astigmatism, Precision7 ™ Multifocal, Precision7 ™ Multifocal Toric 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2023-08-10 P190018-S026 Clareon Intraocular Lenses with the AutonoMe™ Delivery System 30-Day Notice HQL Intraocular Lens Ophthalmic
2023-07-17 P950018-S023 PERFLUORON™ 30-Day Notice LWL Fluid, Intraocular Ophthalmic
2023-06-21 P220007-S001 Precision7, Precision7 for Astigmatism, Precision7 Multifocal, and Precision7 Multifocal Toric 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2023-06-13 P930014-S145 AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems 30-Day Notice HQL Intraocular Lens Ophthalmic
2023-06-13 P190018-S025 Clareon Intraocular Lenses with the AutonoMe™ Delivery System 30-Day Notice HQL Intraocular Lens Ophthalmic
2023-06-02 P030008-S036 WaveLight EX500 Laser System with Patient Bed Swivel 1125 Real-Time Process LZS Excimer Laser System Unknown
2023-06-02 P020050-S040 WaveLight EX500 Laser System with Patient Bed Swivel 1125 Real-Time Process LZS Excimer Laser System Unknown
2023-05-31 P190018-S024 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens 30-Day Notice HQL Intraocular Lens Ophthalmic
2023-04-25 P220007 Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft Conta Original LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2023-03-29 P840064-S079 VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System 30-Day Notice LZP — —
2023-03-09 P190018-S023 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-12-20 P930014-S144 AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-12-20 P190018-S021 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-11-02 P930014-S141 AcrySof™ IOL Sterile UV-Absorbing Acrylic, Foldable Multipiece Posterior Chamber, Lenses, AcrySof™ Natural UV and Blue L Normal 180 Day Track No User Fee HQL Intraocular Lens Ophthalmic
2022-10-28 P930014-S138 AcrySof Posterior Chamber Intraocular Lens 135 Review Track For 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-09-22 P990023-S018 CELLUGEL® Ophthalmic Viscosurgical Devices 30-Day Notice LZP — —
2022-09-15 P990023-S017 CELLUGEL OVD 30-Day Notice LZP — —
2022-09-15 P840064-S078 VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System (consists of PROVISC™ and VISCOAT™), 30-Day Notice LZP — —
2022-09-13 P840064-S077 VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System (consists of PROVISC™ and VISCOAT™), 30-Day Notice LZP — —
2022-08-12 P950018-S021 Perfluoron™ 30-Day Notice LWL Fluid, Intraocular Ophthalmic
2022-07-06 P010019-S083 Lotrafilcon A and B Soft Contact Lenses 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2022-05-18 P930014-S143 AcrySof Posterior Chamber Intraocular Lens and Delivery Systems 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-05-18 P190018-S020 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-05-03 P190018-S019 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre-Loaded Delivery System, Clareon Toric Aspher 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-03-25 P930014-S142 AcrySof Posterior Chamber Intraocular Lens and Delivery Systems 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-02-14 P190018-S012 Clareon PanOptix Trifocal UV Absorbing Hydrophobic Intraocular Lens (IOL), Clareon PanOptix Toric Trifocal Hydrophobic I Normal 180 Day Track No User Fee HQL Intraocular Lens Ophthalmic
2022-01-26 P190018-S013 Clareon Vivity™ Extended Vision Hydrophobic Intraocular Lens (IOL), Clareon Vivity™ Toric Extended Vision Hydrophobic IO Real-Time Process POE — —
2022-01-12 P010019-S081 AIR OPTIX NIGHT & DAY AQUA, AIR OPTIX AQUA, AIR OPTIX AQUA MULTIFOCAL, AIR OPTIX Plus HYDRAGLYDE, AIR OPTIX Plus HYDRAGL 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2021-12-28 P190018-S017 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-12-22 P190018-S016 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon PanOptix Hydrophobic Acrylic IOL 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-12-21 P930014-S140 AcrySof IQ Aspheric IOL with UltraSert 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-12-21 P190018-S015 Clareon Aspheric Hydrophobic Acrylic IOL, Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Preloaded Delivery 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-12-03 P840064-S076 DISCOVISC Ophthalmic Viscosurgical Device Normal 180 Day Track No User Fee LZP — —
2021-12-03 P840064-S075 DISCOVISC™ Ophthalmic Viscosurgical Device Normal 180 Day Track No User Fee LZP — —
2021-12-02 P880087-S031 Single-Piece PMMA Anterior Chamber IOLs Normal 180 Day Track No User Fee HQL Intraocular Lens Ophthalmic
2021-12-02 P840060-S049 Single-Piece PMMA Posterior Chamber IOL Normal 180 Day Track No User Fee HQL Intraocular Lens Ophthalmic
2021-12-01 P190018-S014 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon PanOptix Hydrophobic Acrylic IOL 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-11-23 P950018-S020 Perfluoron 30-Day Notice LWL Fluid, Intraocular Ophthalmic
2021-11-19 P030008-S035 WaveLight EX500 Laser System Real-Time Process LZS Excimer Laser System Unknown
2021-11-19 P020050-S039 WaveLight EX500 Laser System Real-Time Process LZS Excimer Laser System Unknown
2021-09-28 P010019-S080 Lotralcon B soft contact lenses 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2021-09-10 P010019-S079 Lotrafilcon A and B soft contact lenses 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2021-08-27 P010019-S078 Lotrafilcon A and B Soft Contact Lenses for Daily and Extended Wear Normal 180 Day Track No User Fee LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2021-08-23 P930014-S139 AcrySof® Posterior Chamber Intraocular Lens 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-07-14 P930014-S137 AcrySof Posterior Chamber Intraocular Lens 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-07-08 P030008-S034 WaveLight EX500 Laser System Real-Time Process LZS Excimer Laser System Unknown
2021-07-08 P020050-S038 WaveLight EX500 Laser System Real-Time Process LZS Excimer Laser System Unknown
2021-07-01 P930014-S131 AcrySof Intraocular Lenses 135 Review Track For 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-06-22 P930014-S136 AcrySof™ IQ Vivity™ Extended Vision Intraocular Lens (IOL) Real-Time Process POE — —
2021-04-23 P190018-S010 Clareon Aspheric Hydrophobic lOL; Clareon PanOptix Hydrophobic lOL; and Clareon Toric Aspheric Hydrophobic lOL Normal 180 Day Track No User Fee HQL Intraocular Lens Ophthalmic
2021-04-22 P930014-S135 AcrySof Intraocular Lenses 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-04-22 P190018-S011 Clareon Intraocular Lenses with the AutonoMe Delivery System 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-03-15 P190018-S009 Clareon PanOptix Trifocal Hydrophobic IOL, Clareon PanOptix Trifocal UV Absorbing IOL, Clareon PanOptix Trifocal Hydroph Real-Time Process MFK — —
2021-03-03 P840064-S074 VISCOAT Ophthalmic Viscoelastic System, DUOVISC Ophthalmic Viscoelastic System (consists of PRIVSC and VISCOAT) 30-Day Notice LZP — —
2021-02-18 P930014-S132 AcrySof Posterior Chamber Intraocular Lens Normal 180 Day Track No User Fee HQL Intraocular Lens Ophthalmic
2021-02-18 P190018-S005 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (with the AutonoMe Pre-Loaded Delivery System) Claeron Toric Asphe Normal 180 Day Track No User Fee HQL Intraocular Lens Ophthalmic
2021-02-18 P030008-S033 WaveLlght EX500 Laser System Special (Immediate Track) LZS Excimer Laser System Unknown
2021-02-18 P020050-S037 WaveLlght EX500 Laser System Special (Immediate Track) LZS Excimer Laser System Unknown
2020-12-22 P030008-S032 WaveLight Allegretto Wave Excimer Laser System 30-Day Notice LZS Excimer Laser System Unknown
2020-12-22 P020050-S036 WaveLight Allegretto Wave Excimer Laser System 30-Day Notice LZS Excimer Laser System Unknown
2020-12-17 P930014-S134 AcrySof Posterior Chamber Intraocular Lens 30-Day Notice HQL Intraocular Lens Ophthalmic
2020-12-17 P880087-S030 PMMA Single-Piece Anterior Chamber Intraocular Lens 30-Day Notice HQL Intraocular Lens Ophthalmic
2020-12-17 P840060-S048 PMMA Single-Piece Posterior Chamber Intraocular Lens 30-Day Notice HQL Intraocular Lens Ophthalmic
2020-12-14 P010019-S077 Lotrafilcon B soft Contact Lenses for daily and extended wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-11-24 P190018-S008 Clareon Intraocular Lenses with the AutonoMe Delivery System 30-Day Notice HQL Intraocular Lens Ophthalmic
2020-11-12 P190018-S007 Clareon Intraocular Lenses with the AutonoMe Delivery System 30-Day Notice HQL Intraocular Lens Ophthalmic
2020-10-23 P840064-S073 VISCOAT Ophthalmic Viscoelastic System, DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), and DI 30-Day Notice LZP — —
2020-10-02 P930014-S133 AcrySof Posterior Chamber Intraocular Lens 30-Day Notice HQL Intraocular Lens Ophthalmic
2020-09-29 P190018-S006 Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Automated Pre-loaded Delivery System, Clareon Toric Aspheric 30-Day Notice HQL Intraocular Lens Ophthalmic
2020-09-16 P840064-S072 VISCOAT Ophthalmic Viscoelastic System and DUOVISC Ophthalmic Viscoelastic System 30-Day Notice LZP — —
2020-08-21 P030008-S031 WaveLight EX500 Laser Normal 180 Day Track LZS Excimer Laser System Unknown
2020-08-21 P020050-S035 WaveLight EX500 Laser Normal 180 Day Track LZS Excimer Laser System Unknown
2020-07-24 P950018-S019 PERFLUORON 30-Day Notice LWL Fluid, Intraocular Ophthalmic
2020-07-20 P190018-S003 Clareon Aspheric UV Absorbing IOL, Clareon Aspheric UV Absorbing IOL with the AutonoMe Automated Preloaded Delivery Devi Real-Time Process HQL Intraocular Lens Ophthalmic
2020-07-20 P190018-S002 Clareon PanOptix Trifocal Hydrophobic IOL, and Clareon PanOptix Trifocal Hydrophobic IOL with the AutonoMe Automated Pre Real-Time Process MFK — —
2020-07-15 P190018-S001 Clareon and Clareon Toric Intraocular Lenses (IOLs) Normal 180 Day Track HQL Intraocular Lens Ophthalmic
2020-06-16 P190018-S004 Clareon lntraocular Lenses with the AutonoMe Delivery System 30-Day Notice HQL Intraocular Lens Ophthalmic
2020-05-05 P930014-S130 AcrySof (R) Intraocular Lenses 30-Day Notice HQL Intraocular Lens Ophthalmic
2020-04-23 P930014-S129 AcrySof Intraocular Lenses and Delivery System 30-Day Notice HQL Intraocular Lens Ophthalmic
2020-04-02 P840064-S071 DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), DISCOVISC Ophthalmic Viscosurgical Device 30-Day Notice LZP — —
2020-03-19 P010019-S076 Lotrafilcon A Soft Contact Lenses and Lotrafilcon B Soft Contact Lenses 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-02-26 P930014-S126 AcrySof™ IQ Vivity™ Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A Panel Track POE — —
2020-01-22 P010019-S075 Lotrafilcon A and B Soft contact lenses for extended wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-01-09 P930014-S124 AcrySof IQ Aspheric IOL with the UltraSert Pre-Loaded Delivery System Normal 180 Day Track No User Fee HQL Intraocular Lens Ophthalmic
2020-01-07 P190018 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens Original HQL Intraocular Lens Ophthalmic
Filings

All 510(k) clearances (16)

Date K-number Device Code Class Specialty
2026-02-13 K254052 DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal LPL Class II Ophthalmic
2025-09-24 K252682 LenSx Laser System (8065000944) OOE Class II Ophthalmic
2025-04-28 K243896 LenSx Laser System (8065998162) OOE Class II Ophthalmic
2025-01-13 K243909 Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric LPL Class II Ophthalmic
2024-12-04 K242184 Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); MPA Class II Gastroenterology, Urology
2024-06-21 K233876 UNITY VCS (8065000296); UNITY CS (8065000297) HQC — —
2024-01-10 K233902 Centurion™ Vision System (Active Sentry™) (8065753057) HQC — —
2023-12-29 K233856 Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal LPL Class II Ophthalmic
2023-11-16 K232921 DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric LPL Class II Ophthalmic
2023-04-20 K230785 Precision1, Precision1 for Astigmatism LPL Class II Ophthalmic
2022-09-15 K222500 AIR OPTIX COLORS LPL Class II Ophthalmic
2021-12-28 K212806 Alcon (serafilcon A) soft contact lenses for daily wear LPL Class II Ophthalmic
2021-08-23 K212039 CLAREON MONARCH IV IOL Delivery System MSS — —
2021-04-12 K210436 Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere LPL Class II Ophthalmic
2020-09-22 K202448 DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal MVN Class II Ophthalmic
2020-08-21 K202036 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal MVN Class II Ophthalmic
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence