Johnson & Johnson Surgical Vision, Inc.

FDA Regulatory Profile

Summary

Total Recalls
17
510(k) Clearances
4
Inspections
9
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1755-2024Class IIJohnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REMarch 14, 2024
Z-0735-2024Class IITECNIS Toric II OptiBlue IOL Models ZCWDecember 12, 2023
Z-2289-2023Class IITECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx OnlyJuly 6, 2023
Z-2288-2023Class IITECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx OnlyJuly 6, 2023
Z-2247-2023Class IIVERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)May 30, 2023
Z-1006-2023Class IIFUSION Dual Pump Packs, REF: OPO73December 7, 2022
Z-1005-2023Class IIVeritas Advanced Infusion Packs, REF: VRT-AIDecember 7, 2022
Z-1007-2023Class IISingle-Use Packs, REF: OPO80December 7, 2022
Z-0169-2023Class IITHERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-baSeptember 7, 2022
Z-0086-2023Class IIVeritas Advanced Infusion Packs. Used in ophthalmic procedures.September 1, 2022
Z-1033-2022Class IITRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,April 6, 2022
Z-0028-2022Class IITECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bagAugust 6, 2021
Z-1163-2021Class IITECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be pJanuary 27, 2021
Z-0867-2020Class IIHealon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, 10-2715-14, 10-2725-14,December 3, 2019
Z-1893-2019Class IIDisposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The producSeptember 24, 2018
Z-0464-2019Class IIAbbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens ModeJune 21, 2018
Z-0066-2019Class IIOptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label May 9, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K223566ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceApril 14, 2023
K203060VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERIMarch 12, 2021
K191949UNFOLDER Vitan InserterSeptember 13, 2019
K191933COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button FootAugust 16, 2019