Chrysalis Intelligence · Sponsors · Johnson & Johnson Surgical Vision, Inc.

Johnson & Johnson Surgical Vision, Inc.

Santa Ana, CA, US · 2 510(k) clearances · 116 PMAs · 13 recalls

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Total clearances
2
2021-03-12 → 2023-04-14
Last 12 months
0
Product codes
2
Most recent
2023-04-14
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OOE Ophthalmic Femtosecond Laser Class II Ophthalmic 1 2023-04-14
HQC — — — 1 2021-03-12
Class III

PMA approvals (116)

Total PMA records
116
Originals + supplements
Distinct product codes
6
First decision
2020-02-28
Most recent
2026-07-28
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-07-28 P810031-S082 Healon PRO, Healon GV PRO and Healon5 PRO Ophthalmic Viscosurgical Devices (OVD) 30-Day Notice LZP — —
2026-07-23 P980040-S184 SENSARTM 1-Piece IOL, AAB00; TECNISTM 1-Piece IOL with TECNIS Simplicity™ Delivery System, DCB00; TECNISTM 1-Piece OptiB 30-Day Notice HQL Intraocular Lens Ophthalmic
2026-06-03 P990080-S066 TECNIS™ 3-Piece Acrylic Monofocal, Model ZA9003 30-Day Notice HQL Intraocular Lens Ophthalmic
2026-06-03 P980040-S183 SENSAR™ 3-Piece Monofocal IOL, Models, AR40e, AR40E, AR40M, AR40MN 30-Day Notice HQL Intraocular Lens Ophthalmic
2026-06-03 P080010-S031 TECNIS™ 3-Piece Multifocal, Model ZMA00 30-Day Notice MFK — —
2026-05-19 P980040-S182 TECNIS Eyhance™ Toric II IOLs with SmartLOAD™ Delivery Technology (GIU150-600) Real-Time Process MJP Lens, Intraocular, Toric Optics Ophthalmic
2026-03-11 P980040-S176 TECNIS PureSee IOL, Model DEN00V TECNIS PureSee Toric II IOLs, Model DET150, DET225, DET300, DET375 Panel Track HQL Intraocular Lens Ophthalmic
2026-01-12 P990080-S065 TECNIS Foldable Acrylic IOL with OptiEdge, 13.0 mm, ZA9003 30-Day Notice HQL Intraocular Lens Ophthalmic
2026-01-12 P980040-S181 SENSAR 1-piece IOL, AAB00; SENSAR Soft Acrylic Posterior Chamber IOL, Models AR40e, AR40E, and AR40M; TECNIS 1-Piece I 30-Day Notice HQL Intraocular Lens Ophthalmic
2026-01-12 P080010-S030 TECNIS Multi-focal 3-pc, ZMA00 30-Day Notice MFK — —
2025-12-16 P980040-S179 TECNIS SIMPLICITY™ Delivery System 30-Day Notice HQL Intraocular Lens Ophthalmic
2025-12-16 P810031-S081 Healon PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD); Healon Duet PRO II Dual Pack Sodium Hyaluronate Opht 30-Day Notice LZP — —
2025-10-28 P810031-S080 Healon EndoCoat ™ PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD), Healon Duet ™ PRO II Dual Pack Sodium Hya 30-Day Notice LZP — —
2025-10-24 P980040-S178 TECNIS Symfony Toric II OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System, Models DXW150-375; 30-Day Notice HQL Intraocular Lens Ophthalmic
2025-09-11 P980040-S174 TECNIS Odyssey IOL with TECNIS SIMPLICITY Delivery System (DRN00V); TECNIS Odyssey Toric II IOLs with TECNIS SIMPLICITY Real-Time Process — — —
2025-09-10 P990080-S062 TECNIS Foldable Acrylic IOL with OptiEdge Normal 180 Day Track No User Fee HQL Intraocular Lens Ophthalmic
2025-09-10 P980040-S171 SENSAR Soft Acrylic Posterior Chamber IOL, SENSAR 1-piece IOL, TECNIS 1-Piece IOL, TECNIS Multifocal 1-Piece IOL, TECNIS Normal 180 Day Track No User Fee HQL Intraocular Lens Ophthalmic
2025-09-10 P080010-S027 TECNIS Multifocal 3-Piece IOL Normal 180 Day Track No User Fee MFK — —
2025-09-02 P990080-S064 TECNIS 3-Piece Acrylic Monofocal, Model ZA9003 30-Day Notice HQL Intraocular Lens Ophthalmic
2025-09-02 P980040-S177 TECNIS™ Toric II 1-Piece IOLs, ZCU TECNIS Symfony Toric II Extended Range of Vision IOLs, ZXU TECNIS Eyhance Toric II IO 30-Day Notice HQL Intraocular Lens Ophthalmic
2025-09-02 P080010-S029 TECNIS 3-Piece Multifocal, Model ZMA00 30-Day Notice MFK — —
2025-07-22 P990080-S063 TECNIS 3-Piece Acrylic Monofocal, Model ZA9003 30-Day Notice HQL Intraocular Lens Ophthalmic
2025-07-22 P980040-S175 TECNIS Odyssey Toric II IOL with TECNIS SIMPLICITY Delivery System, Model DRT 30-Day Notice HQL Intraocular Lens Ophthalmic
2025-07-22 P080010-S028 TECNIS 3-Piece Multifocal, Model ZMA00 30-Day Notice MFK — —
2025-06-09 P980040-S172 SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS 30-Day Notice HQL Intraocular Lens Ophthalmic
2025-05-29 P980040-S173 Intraocular Lenses (IOLs) in the DaisyWheel and TECNIS SIMPLICITY Delivery System 30-Day Notice HQL Intraocular Lens Ophthalmic
2025-05-01 P810031-S078 HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES Normal 180 Day Track LZP — —
2025-03-11 P810031-S079 Healon PRO OVD, Healon5 PRO OVD, Healon GV PRO OVD 30-Day Notice LZP — —
2025-01-15 P810031-S077 Healon Duet® PRO Dual Pack 30-Day Notice LZP — —
2025-01-15 P110007-S016 Healon EndoCoat® Ophthalmic Viscosurgical Device (OVD) (3% Sodium Hyaluronate) 30-Day Notice LZP — —
2025-01-14 P980040-S170 TECNIS SIMPILICITY™ Delivery System, SmartLOAD Delivery Technology Special (Immediate Track) HQL Intraocular Lens Ophthalmic
2024-12-23 P810031-S076 Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD), Healon Duet® PRO Dual Pack 30-Day Notice LZP — —
2024-12-23 P110007-S015 Healon EndoCoat® Ophthalmic Viscosurgical Device (OVD) (3% Sodium Hyaluronate) 30-Day Notice LZP — —
2024-12-19 P990080-S061 TECNIS 3-Piece Acrylic Monofocal 30-Day Notice HQL Intraocular Lens Ophthalmic
2024-12-19 P980040-S169 SENSAR 1-Piece IOL with SmartLOAD Delivery Technology, TECNIS 1-Piece IOL with SmartLOAD Delivery Technology, TECNIS Opt 30-Day Notice HQL Intraocular Lens Ophthalmic
2024-12-19 P080010-S026 TECNIS 3-Piece Multifocal 30-Day Notice MFK — —
2024-09-27 P990080-S057 TECNIS® 3-Piece Acrylic Monofocal 135 Review Track For 30-Day Notice HQL Intraocular Lens Ophthalmic
2024-09-27 P980040-S160 TECNIS 1-Piece IOL with TECNIS® iTec Preloaded Delivery System, SENSAR® 3-Piece Monofocal IOL 135 Review Track For 30-Day Notice HQL Intraocular Lens Ophthalmic
2024-09-27 P880081-S048 TECNIS® CL Foldable Silicone IOL 135 Review Track For 30-Day Notice — — —
2024-09-27 P080010-S022 TECNIS® 3-Piece Multifocal 135 Review Track For 30-Day Notice MFK — —
2024-06-17 P990080-S060 TECNIS® Foldable Acrylic IOL with OptiEdge, Model ZA9003 30-Day Notice HQL Intraocular Lens Ophthalmic
2024-06-17 P980040-S168 SENSAR® Soft Acrylic Posterior Chamber IOL 30-Day Notice HQL Intraocular Lens Ophthalmic
2024-06-17 P080010-S025 TECNIS® Multifocal 3-Piece IOL, Model ZMA00 30-Day Notice MFK — —
2024-04-15 P810031-S075 Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon Duet PRO Dual Pack Normal 180 Day Track LZP — —
2024-04-15 P110007-S014 Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) (3% Sodium Hyaluronate) Normal 180 Day Track LZP — —
2023-12-22 P980040-S161 TECNIS Symfony™ Extended Range Of Vision Intraocular Lens Normal 180 Day Track No User Fee POE — —
2023-12-22 P980040-S159 TECNIS Odyssey Toric II Intraocular Lens (IOL) With TECNIS Simplicity Delivery System, Models DRT150, DRT225, DRT300, DR Normal 180 Day Track HQL Intraocular Lens Ophthalmic
2023-10-19 P980040-S163 TECNIS Simplicity Delivery System, SmartLOAD Delivery Technology, TECNIS iTec Preloaded Delivery System Real-Time Process HQL Intraocular Lens Ophthalmic
2023-09-27 P990080-S059 TECNIS Foldable Acrylic IOL with OptiEdge 30-Day Notice HQL Intraocular Lens Ophthalmic
2023-09-27 P980040-S165 SENSAR® Soft Acrylic Posterior Chamber IOL 30-Day Notice HQL Intraocular Lens Ophthalmic
2023-09-27 P080010-S024 TECNIS Multifocal 3-Piece, TECNIS Foldable Acrylic IOL with OptiEdge 30-Day Notice MFK — —
2023-09-19 P810031-S073 Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon® PRO, Healon GV® PRO, Healon5® PRO and Healon® Duet PRO 135 Review Track For 30-Day Notice LZP — —
2023-08-21 P980040-S162 SENSAR® 1-piece IOL, AAB00, TECNIS® 1-Piece IOL with TECNIS Simplicity™ Delivery System, DCB00, TECNIS® 1-Piece OptiBlue 30-Day Notice HQL Intraocular Lens Ophthalmic
2023-05-23 P980040-S156 TECNIS Next-Generation Presbyopia-Correcting IOL Normal 180 Day Track MFK — —
2023-04-20 P980040-S158 TECNIS® 1-Piece IOL with TECNIS Simplicity™ Delivery System, TECNIS® OptiBlue™ 1-Piece IOL with TECNIS Simplicity™ Deliv 30-Day Notice HQL Intraocular Lens Ophthalmic
2023-03-13 P810031-S074 Healon® PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device, Healon Duet® PRO Dual Pack, Healon GV® PRO Sodium Hyaluro 30-Day Notice LZP — —
2023-03-06 P980040-S157 TECNIS® Toric II 1-Piece IOLs, TECNIS Symfony™ Toric II Extended Range of Vision IOLs, TECNIS Eyhance™ IOL, TECNIS Eyhan 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-12-15 P980040-S154 TECNIS 1-Piece IOL with TECNIS® iTEC Preloaded Delivery System Model PCB00, TECNIS Multifocal 1-PC IOL with TECNIS® iTEC 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-12-12 P980040-S155 TECNIS Eyhance™ IOL with TECNIS Simplicity™ Delivery System, Model DIB00, TECNIS Eyhance™ Toric II IOLs with TECNIS Simp 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-12-06 P990080-S056 TECNIS® Foldable Acrylic IOL 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-12-06 P980040-S153 SENSAR® 3-Piece Monofocal IOLs, SENSAR 1-Piece IOL, TECNIS Monofocal 1-Piece IOL, TECNIS Multifocal 1-Piece IOL, TECNIS 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-12-06 P880081-S047 TECNIS® CL Foldable Silicone Posterior Chamber IOL 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-12-06 P080010-S021 TECNIS® Multifocal Foldable Posterior Chamber IOL 30-Day Notice MFK — —
2022-11-17 P980040-S152 SENSAR® 1-Piece IOL, Model AAB00, TECNIS® Monofocal 1-Piece IOL, Model ZCB00, TECNIS® Multifocal 1-Piece IOL, Model ZMB0 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-10-27 P980040-S151 JJSV's One-Piece IOL's with Daisy-Whell packaging configuration, JJSV's One-Piece IOLs with TECNIS SmartLOAD Delivery Te 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-10-07 P980040-S150 SENSAR® 1-piece IOL, TECNIS® 1-Piece IOL, SENSAR® 1-piece IOL with SmartLOADTM Delivery Technology, TECNIS® 1-piece IOL 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-07-25 P980040-S149 TECNIS® Symfony™, TECNIS® Symfony™ Toric, TECNIS® Symfony™ OptiBlue®, TECNIS® Symfony™ OptiBlue® with TECNIS Simplicity® 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-07-20 P980040-S148 TECNIS Eyhance™ Toric II, Model ICU, TECNIS Eyhance™ Toric II with TECNIS Simplicity® Delivery System, TECNIS Synergy™ T 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-05-18 P980040-S147 JJSV’s intraocular lenses (IOLs) 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-03-30 P980040-S146 TECNIS IOLs 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-02-17 P980040-S145 TECNIS® Toric II 1-Piece IOLs, TECNIS Symfony™ Toric II Extended Range of Vision IOLs, TECNIS® Multifocal Toric II IOLs, 30-Day Notice HQL Intraocular Lens Ophthalmic
2022-02-16 P810031-S070 Healon PRO, Healon GV PRO, Healon 5 PRO Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD) Normal 180 Day Track LZP — —
2022-02-14 P980040-S144 The SENSAR 1-Piece IOL with SmartLOAD Delivery Technology, The TECNIS 1-Piece IOL with SmartLOAD Delivery Technology, Th Normal 180 Day Track HQL Intraocular Lens Ophthalmic
2021-12-23 P980040-S142 TECNIS Symfony™ OptiBlue® Extended Range of Vision (ERV) IOL with TECNIS Simplicity® Delivery System, Model DXR00V; TECN Real-Time Process HQL Intraocular Lens Ophthalmic
2021-12-01 P980040-S140 TECNIS Symfony Toric II OptiBlue Extended Range of Vision (ERV) IOL 135 Review Track For 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-11-17 P810031-S071 Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon PRO, Healon GV PRO, Healon5 PRO and Healon Duet PRO Dua 135 Review Track For 30-Day Notice LZP — —
2021-11-15 P980040-S139 TECNIS Symfony OptiBlue Extended Range of Vision (ERV) IOL, TECNIS Symfony Toric II OptiBlue Extended Range of Vision (E 135 Review Track For 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-09-10 P980040-S133 TECNIS Simplicity Delivery System; SmartLOAD Delivery Technology 135 Review Track For 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-07-28 P980040-S141 TECNIS Family of 1-piece IOLs packaged in the Daisy Wheel Configuration 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-07-13 P810031-S072 Sodium Hyaluronate OphthalmicViscoelastic Devices (OVD), Healon PRO, Healon GV PRO, Healon5 PRO and Healon Duet PRO Dual 30-Day Notice LZP — —
2021-06-29 P980040-S138 TECNIS Synergy IOL with TECNIS Simplicity Delivery System, TECNIS Synergy Toric II IOL with TECNIS Simplicity Delivery S 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-06-29 P980040-S137 TECNIS Simplicity Delivery System 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-06-16 P980040-S136 TECNIS Symfony Toric Extended Range of Vision IOLs Normal 180 Day Track No User Fee HQL Intraocular Lens Ophthalmic
2021-06-07 P980040-S135 TECNIS Synergy™ IOL with TECNIS Simplicity® Delivery System, TECNIS Synergy™ Toric II IOL with TECNIS Simplicity® Delive 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-05-04 P980040-S134 TECNIS Simplicity Delivery System 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-04-28 P980040-S124 TECNIS Synergy Intraocular Lens, TECNIS Synergy Toric II Intraocular Lens, TECNIS Synergy IOL with TECNIS Simplicity Del Panel Track MFK — —
2021-03-23 P980040-S132 TECNIS Symfony™ OptiBlue™ Extended Range of Vision (ERV) IOL 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-03-08 P980040-S131 TECNIS Symfony Toric II OptiBlue Extended Range of Vision (ERV) IOLs 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-02-22 P980040-S130 SENSAR 1-Piece IOL with Smart LOAD Delivery Technology, TECNIS 1-Piece IOL with Smart LOAD Delivery Technology, TECNIS O 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-01-26 P980040-S129 TECNIS Simplicity Delivery System 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-01-08 P990080-S055 TECNIS Foldable Acrylic IOL 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-01-08 P980040-S128 TECNIS OptiBlue 1-Piece IOL, TECNIS OptiBlue Monofocal 1-Piece with Smart LOAD Delivery Technology, TECNIS 1-Piece OptiB 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-01-08 P980040-S127 SENSAR 3-Piece Monofocal IOLs with OptiEdge Design, SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, TECNIS Multifocal 1-Piece IO 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-01-08 P880081-S046 TECNIS CL Foldable Silicone Posterior Chamber IOL 30-Day Notice HQL Intraocular Lens Ophthalmic
2021-01-08 P080010-S020 TECNIS Multifocal Foldable Posterior Chamber IOL 30-Day Notice MFK — —
2020-12-29 P980040-S117 TECNIS Eyhance IOL, TECNIS Eyhance IOL with SmartLOAD Delivery Technology, TECNIS Eyhance IOL with TECNIS Simplicity Del Normal 180 Day Track HQL Intraocular Lens Ophthalmic
2020-12-16 P810031-S069 Healon PRO Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon Duet PRO Dual Pack, Healon GV PRO Sodium Hya 30-Day Notice LZP — —
2020-12-02 P810031-S068 Ophthalmic Viscoelastic Devices, Healon Duet Dual Pack and Healon Duet PRO Dual Pack 30-Day Notice LZP — —
2020-12-02 P110007-S013 Healon EndoCoat Ophthalmic Viscosurgical Device (3% Sodium Hyaluronate) 30-Day Notice LZP — —
2020-11-25 P810031-S066 Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD), Healon GV PRO Normal 180 Day Track LZP — —
2020-11-12 P990080-S054 TECNIS Foldable Acrylic IOL 30-Day Notice HQL Intraocular Lens Ophthalmic
2020-11-12 P980040-S126 SENSAR 3-Piece Monofocal IOLs, SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, TECNIS OptiBlue 1-Piece IOL, TECNIS Multifocal 1- 30-Day Notice HQL Intraocular Lens Ophthalmic
2020-11-04 P980040-S118 TECNIS 1-Piece IOL with TECNIS Simplicity Delivery System, TECNIS OptiBlue 1-Piece IOL with TECNIS Simplicity Delivery S Normal 180 Day Track No User Fee HQL Intraocular Lens Ophthalmic
2020-11-03 P980040-S123 TECNIS Symfony Toric II OptiBlue Extended Range of Vision Intraocular Lenses 30-Day Notice HQL Intraocular Lens Ophthalmic
2020-10-26 P980040-S120 TECNIS Multifocal Toric II Intraocular Lenses Normal 180 Day Track No User Fee HQL Intraocular Lens Ophthalmic
2020-10-14 P980040-S115 TECNIS Toric 1-Piece Intraocular Lense (IOLs) Normal 180 Day Track No User Fee HQL Intraocular Lens Ophthalmic
2020-09-23 P980040-S122 TECNIS iTEC Preloaded Delivery System, TECNIS Simplicity Delivery System 30-Day Notice HQL Intraocular Lens Ophthalmic
2020-09-23 P980040-S121 One-Piece IOLs with Daisy-Wheel packaging configuration, One-Piece IOLs with TENIC iTEC Preloaded Delivery System, One-P 30-Day Notice HQL Intraocular Lens Ophthalmic
2020-08-27 P980040-S113 TECNIS Toric II 1-Piece IOLs, TECNIS Symfony Toric II Extended Range of Vision IOLs Normal 180 Day Track No User Fee HQL Intraocular Lens Ophthalmic
2020-08-03 P980040-S119 One-Piece IOLs with Daisy-Wheel packaging configuration, TENIC iTEC Preloaded Delivery System, TECNIS SmartLOAD Delivery 30-Day Notice HQL Intraocular Lens Ophthalmic
2020-06-11 P980040-S111 TECNIS Toric 1-Piece Intraocular Lenses (IOL) Normal 180 Day Track No User Fee MJP Lens, Intraocular, Toric Optics Ophthalmic
2020-05-28 P980040-S112 TECNIS Symfony OptiBlue IOL, TECNIS Symfomy Toric II OptiBlue IOLs Real-Time Process POE — —
2020-05-11 P810031-S067 Sodium Hyaluronate Ophtalmic Viscoelastic Devices (OVD), Healon Duet Dual Pack and Healon Duet PRO Dual Pack 30-Day Notice LZP — —
2020-05-11 P110007-S012 Healon EndoCoat Ophtalmic Viscosurgical Devices (OVD) (3% Sodium Hyaluronate) 30-Day Notice LZP — —
2020-05-01 P980040-S109 TECNIS Symfony PLUS Extended Range of Vision Intraocular Lens (IOL), Model ZHR00, TECNIS Symfony PLUS Extended Range of Normal 180 Day Track POE — —
2020-02-28 P980040-S107 Tecnis Multifocal Toric II Intraocular Lenses (IOL) Normal 180 Day Track HQL Intraocular Lens Ophthalmic
Safety

Recalls (13)

Class I (serious)
0
Risk of injury / death
Total recalls
13
Currently ongoing
11
Most recent
2024-03-14
DateSeverityStatusRecall # ProductCodeReason
2024-03-14 Class II Ongoing Z-1755-2024 Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The ir… — Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to coo…
2023-12-12 Class II Ongoing Z-0735-2024 TECNIS Toric II OptiBlue IOL Models ZCW — Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle betw…
2023-07-06 Class II Ongoing Z-2289-2023 TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only — Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
2023-07-06 Class II Ongoing Z-2288-2023 TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only — Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
2023-05-30 Class II Ongoing Z-2247-2023 VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF) — Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, which could lead to priming cycl…
2022-12-07 Class II Ongoing Z-1007-2023 Single-Use Packs, REF: OPO80 — Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or subopti…
2022-12-07 Class II Ongoing Z-1006-2023 FUSION Dual Pump Packs, REF: OPO73 — Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or subopti…
2022-12-07 Class II Ongoing Z-1005-2023 Veritas Advanced Infusion Packs, REF: VRT-AI — Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or subopti…
2022-09-07 Class II Ongoing Z-0169-2023 THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrop… — Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of…
2022-09-01 Class II Ongoing Z-0086-2023 Veritas Advanced Infusion Packs. Used in ophthalmic procedures. — As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.
2022-04-06 Class II Ongoing Z-1033-2022 TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only, — Potential breach in the sterility barrier for tray ring covers.
2021-08-06 Class II Terminated Z-0028-2022 TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simpli… — Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification lim…
2021-01-27 Class II Terminated Z-1163-2021 TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsula… — Due to the release of nonconforming Intraocular Lenses (IOLs).
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2023-04-14 K223566 ELITA™ Femtosecond Laser System, ELITA™ Patient Interface OOE Class II Ophthalmic
2021-03-12 K203060 VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control HQC — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence