Johnson & Johnson Surgical Vision, Inc.
Johnson & Johnson Surgical Vision, Inc. holds FDA 510(k) medical device clearances, first cleared 2019, most recent 2023, with 18 FDA device recalls on record.
Top product codes for Johnson & Johnson Surgical Vision, Inc.
FDA recalls by Johnson & Johnson Surgical Vision, Inc.
10 most recent of 18- Z-3064-2026 — 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)
- Z-1755-2024 — 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 shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.
- Z-0735-2024 — TECNIS Toric II OptiBlue IOL Models ZCW
- Z-2288-2023 — TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only
- Z-2289-2023 — TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
- Z-2247-2023 — VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
- Z-1005-2023 — Veritas Advanced Infusion Packs, REF: VRT-AI
- Z-1007-2023 — Single-Use Packs, REF: OPO80
- Z-1006-2023 — FUSION Dual Pump Packs, REF: OPO73
- Z-0169-2023 — 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 generator, for cardiac ablation.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Johnson & Johnson Surgical Vision, Inc.
- K223566 — ELITA Femtosecond Laser System, ELITA Patient Interface
- K203060 — VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control
- K191949 — UNFOLDER Vitan Inserter
- K191933 — COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal
Data sourced from openFDA. This site is unofficial and independent of the FDA.