Recall Register

Food, drugs, devices › Firms

Johnson & Johnson Surgical Vision, Inc.

FDA recalling firm · 15 enforcement events · 18 product records · 2018–2026 · CA

Johnson & Johnson Surgical Vision, Inc. has 15 FDA enforcement events on this register (18 product records) between 2018 and 2026: 15 device; the busiest year was 2022 with 4.

0% of its events are Class I; the most common class is Class II (15). 9 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

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

By type and class

Device15
Class II15

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

18
19
20
21
22
23
24
25
26
Enforcement events for Johnson & Johnson Surgical Vision, Inc. by year initiated.

Questions and answers

How many FDA recalls has Johnson & Johnson Surgical Vision, Inc. had?

15 enforcement events (18 product records) on this register, 2018–2026: 15 device.

Are any Johnson & Johnson Surgical Vision, Inc. recalls ongoing?

9 events are listed as ongoing in the current openFDA export.

What class are Johnson & Johnson Surgical Vision, Inc. recalls?

15 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.