Company · US
Johnson & Johnson Surgical Vision, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2023. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
18recalls (1 in 12 months)
9recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HQC | Unit, Phacofragmentation | 9 |
| MJP | Lens, Intraocular, Toric Optics | 3 |
| HQL | Intraocular Lens | 2 |
| LZP | Aid, Surgical, Viscoelastic | 2 |
| OOE | Ophthalmic Femtosecond Laser | 2 |
| MLZ | Vitrectomy, Instrument Cutter | 1 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 1 |
| OAD | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | 1 |
| POE | Extended Depth Of Focus Intraocular Lens | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 14, 2023 | K223566 | ELITA Femtosecond Laser System, ELITA Patient Interface Johnson & Johnson Surgical Vision, Inc. | OOE |
| Mar 12, 2021 | K203060 | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece Johnson & Johnson Surgical Vision, Inc. | HQC |
| Sep 13, 2019 | K191949 | UNFOLDER Vitan Inserter Johnson & Johnson Surgical Vision, Inc. | MSS |
| Aug 16, 2019 | K191933 | COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTU Johnson & Johnson Surgical Vision, Inc. | HQC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2026 | Johnson & Johnson Surgical Vision, Inc. HEALON EndoCoat PRO, REF: 10300012 (US/CAN)
HEALON DUET PRO II, REF: 10300016 (US/CAN)
HEALON EndoCoat PRO, REF: 10301012 (EU);
HEALON DUET PRO II, REF: 10301016 (EU) Open, Classified |
LZP | None listed |
| May 2, 2024 | Johnson & 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 |
HQC | K121721 |
| Jan 16, 2024 | Johnson & Johnson Surgical Vision, Inc. TECNIS Toric II OptiBlue IOL Models ZCW Open, Classified |
MJP | None listed |
| Aug 3, 2023 | Johnson & Johnson Surgical Vision, Inc. TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only Open, Classified |
HQL | None listed |
| Aug 3, 2023 | Johnson & Johnson Surgical Vision, Inc. TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only Open, Classified |
POE | None listed |
| Jul 28, 2023 | Johnson & Johnson Surgical Vision, Inc. VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF) Open, Classified |
HQC | K203060 |
| Jan 20, 2023 | Johnson & Johnson Surgical Vision, Inc. Single-Use Packs, REF: OPO80 Open, Classified |
HQC | K133115 |
| Jan 20, 2023 | Johnson & Johnson Surgical Vision, Inc. FUSION Dual Pump Packs, REF: OPO73 Open, Classified |
HQC | K160236 |
| Jan 20, 2023 | Johnson & Johnson Surgical Vision, Inc. Veritas Advanced Infusion Packs, REF: VRT-AI Open, Classified |
HQC | K203060 |
| Nov 2, 2022 | Johnson & Johnson Surgical Vision, Inc. THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in conjunction with an RF Open, Classified |
OAD | None listed |
| Oct 12, 2022 | Johnson & Johnson Surgical Vision, Inc. Veritas Advanced Infusion Packs. Used in ophthalmic procedures. Open, Classified |
HQC | K203060 |
| Apr 6, 2022 | Johnson & Johnson Surgical Vision Inc TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only, Open, Classified |
HQC | K951462 |
| Aug 6, 2021 | Johnson & Johnson Surgical Vision Inc TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular ca Terminated |
MJP | None listed |
| Jan 27, 2021 | Johnson & Johnson Surgical Vision Inc TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag. Terminated |
MJP | None listed |
| Jan 27, 2020 | Johnson & Johnson Surgical Vision Inc Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, 10-2715-14, 10-2725-14, and 10-2755-14 Terminated |
LZP | None listed |
| Nov 14, 2018 | Johnson & Johnson Surgical Vision Inc Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses are indicated for the visual correction of aphakia Terminated |
HQL | None listed |
| Sep 24, 2018 | Johnson & Johnson Surgical Vision Inc Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc.,
The product provides the item necessary to perform one vitrectomy procedure. It is used to remove vitreous from Terminated |
MLZ | K081681 |
| May 9, 2018 | Johnson & Johnson Surgical Vision Inc OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33
Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMe Terminated |
OOE | K113479 K121091 +3 |