Recall Register

Johnson & Johnson Surgical Vision, Inc.: FDA recalls

FDA enforcement events from 2018 to 2026; export dated . The recall start date and FDA report date are separate fields. Read the recall classes.

FDA enforcement reports name Johnson & Johnson Surgical Vision, Inc. as the recalling firm in 15 events. The events have 18 product records. The recalls started from 2018 to 2026. All the events are device recalls. By FDA enforcement events, Johnson & Johnson Surgical Vision, Inc. is number 233 of 1,628 firms that have a page. Events that Johnson & Johnson Surgical Vision, Inc. started: 1 in 2024 and none in 2025. For all FDA enforcement events, the count rose by 3.6%, from 1,773 in 2024 to 1,836 in 2025. Class II is 100.0% of its events and 73.7% of all FDA events.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

15 events, newest first.

FDA enforcement events of Johnson & Johnson Surgical Vision, Inc.
InitiatedProduct (first record)TypeClassRecordsStatus
31 Jul 2026HEALON 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)DeviceClass II1Ongoing
14 Mar 2024Johnson & 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.DeviceClass II1Ongoing
12 Dec 2023TECNIS Toric II OptiBlue IOL Models ZCWDeviceClass II1Ongoing
6 Jul 2023TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx OnlyDeviceClass II2Ongoing
30 May 2023VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)DeviceClass II1Ongoing
7 Dec 2022Veritas Advanced Infusion Packs, REF: VRT-AIDeviceClass II3Ongoing
7 Sep 2022THERMOCOOL 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.DeviceClass II1Ongoing
1 Sep 2022Veritas Advanced Infusion Packs. Used in ophthalmic procedures.DeviceClass II1Ongoing
6 Apr 2022TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,DeviceClass II1Ongoing
6 Aug 2021TECNIS 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…DeviceClass II1Terminated
27 Jan 2021TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.DeviceClass II1Terminated
3 Dec 2019Healon 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 10-2755-14DeviceClass II1Terminated
24 Sep 2018Disposable 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)DeviceClass II1Terminated
21 Jun 2018Abbott 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…DeviceClass II1Terminated
9 May 2018OptiMedica 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,…DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Johnson & Johnson Surgical Vision, Inc.: events for each product type
TypeEvents
Device15
Johnson & Johnson Surgical Vision, Inc.: events in each class
ClassEvents
Class II15
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
9

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Johnson & Johnson Surgical Vision, Inc., by the year that the recall started. The largest year is 2022, with 4 events.

Official channels

Cite this page

Recall Register. Johnson & Johnson Surgical Vision, Inc.: FDA recalls. https://recallregister.com/firm/johnson-johnson-surgical-vision-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
3 Nov 2026
State of the firm address
CA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not rate one firm against another. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Johnson & Johnson Surgical Vision, Inc. have?
Class II: 15 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Johnson & Johnson Surgical Vision, Inc.?
FDA event 99496, which the firm started on 31 Jul 2026. The first product in the record is: 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)
How many FDA recalls of Johnson & Johnson Surgical Vision, Inc. have the status Ongoing?
9 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.