17 results
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90ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
FDA Recall
Open, Classified
·Johnson & Johnson Surgical Vision Inc·Product code HQC·April 6, 2022
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.
FDA Recall
Open, Classified
·Johnson & Johnson Surgical Vision, Inc.·Product code HQC·March 14, 2024
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.
FDA Recall
Open, Classified
·Johnson & Johnson Surgical Vision, Inc.·Product code OAD·September 7, 2022
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
FDA Recall
Terminated
·Johnson & Johnson Surgical Vision Inc·Product code LZP·December 3, 2019
TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only
FDA Recall
Open, Classified
·Johnson & Johnson Surgical Vision, Inc.·Product code POE·July 6, 2023
Single-Use Packs, REF: OPO80
FDA Recall
Open, Classified
·Johnson & Johnson Surgical Vision, Inc.·Product code HQC·December 7, 2022
TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
FDA Recall
Open, Classified
·Johnson & Johnson Surgical Vision, Inc.·Product code HQL·July 6, 2023
Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
FDA Recall
Open, Classified
·Johnson & Johnson Surgical Vision, Inc.·Product code HQC·September 1, 2022
Veritas Advanced Infusion Packs, REF: VRT-AI
FDA Recall
Open, Classified
·Johnson & Johnson Surgical Vision, Inc.·Product code HQC·December 7, 2022
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 the eye. It has been designed as a disposable (single use)
FDA Recall
Terminated
·Johnson & Johnson Surgical Vision Inc·Product code MLZ·September 24, 2018
VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
FDA Recall
Open, Classified
·Johnson & Johnson Surgical Vision, Inc.·Product code HQC·May 30, 2023
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 in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.
FDA Recall
Terminated
·Johnson & Johnson Surgical Vision Inc·Product code HQL·June 21, 2018
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: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers: 46120916; 46123116, 46124617; 46131418, and 46131618 label states "Manufactured for: OptiMedica Corporation 510 Cottonwood Drive Milpitas, CA 95035 USA The Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
FDA Recall
Terminated
·Johnson & Johnson Surgical Vision Inc·Product code OOE·May 9, 2018
TECNIS Toric II OptiBlue IOL Models ZCW
FDA Recall
Open, Classified
·Johnson & Johnson Surgical Vision, Inc.·Product code MJP·December 12, 2023
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 cartridge that functions as both the primary packaging and as a sterile, disposable insertion system for delivering the IOL into the eye during cataract surgery.
FDA Recall
Terminated
·Johnson & Johnson Surgical Vision Inc·Product code MJP·August 6, 2021
TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.
FDA Recall
Terminated
·Johnson & Johnson Surgical Vision Inc·Product code MJP·January 27, 2021
FUSION Dual Pump Packs, REF: OPO73
FDA Recall
Open, Classified
·Johnson & Johnson Surgical Vision, Inc.·Product code HQC·December 7, 2022