The Recall Desk

Manufacturer

Johnson & Johnson Surgical Vision, Inc.

17 recalls in our database name Johnson & Johnson Surgical Vision, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
17
Critical
0
Severe
0
Most recent
2024-05-08

Of the 17 recalls from Johnson & Johnson Surgical Vision, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–17 of 17

  • HighFDA (Devices)·Z-1755-2024·2024-05-08

    Johnson & Johnson Irrigation Sleeve Recalled for Manufacturing Defect

    Johnson & Johnson is recalling 3,428 reusable irrigation sleeves due to manufacturing defects that could impair cooling during eye surgery, potentially causing anterior chamber instability and patient harm.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0735-2024·2024-01-24

    Intraocular Lens Cylinder Axis Marks Out of Specification

    Johnson & Johnson is recalling TECNIS Toric II intraocular lenses distributed in Japan. The cylinder axis marks do not meet product specifications and could affect vision correction.

    Product
    TECNIS Toric II OptiBlue IOL Models ZCW
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2247-2023·2023-08-09

    VERITAS Advanced Infusion and Fluidics Packs Recalled for Weld Defect

    Johnson & Johnson is recalling 148,941 VERITAS Advanced Infusion and Fluidics surgical packs due to weld defects that could cause vacuum failure during surgery, potentially leading to surgical delays and temporary eye swelling.

    Product
    VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2288-2023·2023-08-09

    TECNIS Symfony Intraocular Lenses Recalled for Unintended Fiducial Marks

    Johnson & Johnson is recalling 42 TECNIS Symfony intraocular lenses that may have been manufactured with unintended toric fiducial marks. The lenses are surgical implants used to restore vision.

    Product
    TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2289-2023·2023-08-09

    Intraocular Lenses Recalled Due to Unintended Fiducial Marks

    Johnson & Johnson is recalling 61 TECNIS Eyhance intraocular lenses that may have been manufactured with unintended toric fiducial marks, which could affect proper surgical positioning. The affected units were distributed to China, India, and Korea.

    Product
    TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1006-2023·2023-02-01

    FUSION Dual Pump Packs recalled for weld defect affecting surgery

    FUSION Dual Pump Packs are being recalled for weld defects that may impair vacuum delivery during eye surgery, risking surgical delays and corneal swelling. No injuries have been reported.

    Product
    FUSION Dual Pump Packs, REF: OPO73
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1005-2023·2023-02-01

    Veritas Advanced Infusion Packs Recalled Due to Weld Gap Defect

    Johnson & Johnson Surgical Vision is recalling Veritas Advanced Infusion Packs for a weld defect that may impair vacuum delivery during ophthalmic surgery. This could result in surgical delays and transient corneal swelling.

    Product
    Veritas Advanced Infusion Packs, REF: VRT-AI
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0169-2023·2022-11-09

    Cardiac Navigation Catheter Recalled for Cellulose Fiber Contamination

    Johnson & Johnson is recalling 91 THERMOCOOL SMARTTOUCH SF cardiac catheters nationwide due to manufacturing defects introducing cellulose fibers into the irrigation system. The contamination may prevent proper flushing, reduce cooling capability, or cause clotting complications.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0086-2023·2022-10-19

    Veritas Advanced Infusion Packs Recalled for Broken Irrigation Luer

    Johnson & Johnson Surgical Vision is recalling 53,624 units of Veritas Advanced Infusion Packs due to manufacturing defects causing broken or cracked irrigation luers that could compromise ophthalmic surgical procedures.

    Product
    Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-1033-2022·2022-05-11

    Johnson & Johnson Tray Ring Covers Recalled for Sterility Barrier Breach

    Johnson & Johnson Surgical Vision is recalling tray ring covers (Model OM271000) worldwide due to a potential breach in the sterility barrier that could allow contamination.

    Product
    TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0028-2022·2021-10-13

    FDA Recalls TECNIS Eyhance Intraocular Lenses for Elevated Endotoxin

    Johnson & Johnson is recalling TECNIS Eyhance intraocular lenses due to elevated endotoxin levels exceeding internal and FDA specification limits. Affected lenses were distributed nationwide in Illinois.

    Product
    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, disposabl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1163-2021·2021-03-10

    Johnson & Johnson Recalls Nonconforming TECNIS Toric Intraocular Lenses

    Johnson & Johnson Surgical Vision Inc is recalling 27 TECNIS Toric 1-Piece Intraocular Lenses due to the release of nonconforming products.

    Product
    TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0867-2020·2020-02-05

    Johnson & Johnson Recalls Healon GV PRO Ophthalmic Viscosurgical Devices

    Johnson & Johnson is recalling Healon GV PRO ophthalmic viscosurgical devices because they may be difficult to remove from the eye, potentially causing increased pressure or equipment clogging.

    Product
    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
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-1893-2019·2019-07-10

    Recall of 25GA Vitrectomy Cutters Due to Packaging Error

    Johnson & Johnson is recalling 392 units of 25GA Vitrectomy Cutters because 20GA cutters may be found in the packaging, posing a surgical risk.

    Product
    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)
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0464-2019·2018-11-21

    Abbott TECNIS Intraocular Lenses Recalled for Expiration Date Violations

    Johnson & Johnson Surgical Vision is recalling 17 expired Abbott TECNIS intraocular lenses distributed in seven US states.

    Product
    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 c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0066-2019·2018-10-10

    OptiMedica Catalys Precision Laser System Recalled for Software Alignment Failures

    Johnson & Johnson is recalling nine Catalys Precision Laser Systems because a software upgrade causes alignment verification cuts to mismatch the intended treatment overlay.

    Product
    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 La
    Category
    Medical Device
    Distribution
    5 states