Irvine, CA, United States
Johnson & Johnson Surgical Vision, Inc. recalls
15 recalls recorded since 2018, most recently on 31 July 2026. 9 are listed as ongoing. Status and classification are as published by the FDA.
Recalls15
Ongoing (FDA)9
Terminated or completed6
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 31 July 2026
- Reason
- Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding because forcing the cannula may cause corneal abrasion, iris trauma or descemet's membrane detachment.
- Distribution
- Worldwide - US Nationwide distribution including in the states of PA, AL, AZ, AR, CA, FL, IL, IN, IA, KY, LA, ME, MI, MN, MS, NJ, NY, NC, OH, OR, TN, TX, WA, WV, HI, CO, MD, VA, WI, ID, NH, SD, OK, MA, NM, DE, GA, SC, CT, NV, MO, RI, KS, ND and the countries of CA, BE, CH, DE, DK, ES, FR GB, HU, IS,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3064-2026
- 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)
Ongoing Class II Medical devices
- Recall started
- 14 March 2024
- Reason
- Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially leading to an unstable anterior chamber which could cause possible harms.
- Distribution
- U.S. Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, LA, MA, MD, ME, MN, MO, NC, NJ, NY, OR, PA, SC, TX, VA, WA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1755-2024
- 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 phacoemulsi
Ongoing Class II Medical devices
- Recall started
- 12 December 2023
- Reason
- Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks.
- Distribution
- International distribution to the country of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0735-2024
- TECNIS Toric II OptiBlue IOL Models ZCW
Ongoing Class II Medical devices
- Recall started
- 6 July 2023
- Reason
- Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
- Distribution
- International distribution to the countries of China, India, Korea.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2288-2023, Z-2289-2023
- TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only
- TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
Ongoing Class II Medical devices
- Recall started
- 30 May 2023
- Reason
- Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.
- Distribution
- Worldwide - US Nationwide distribution including in the states of NC, OH, NY, IN, FL, TN, CA, PA, AZ, AL, TX, WA, WV, MS, GA, UT, KY, IA, MO, AR, DE, IL, WI, VA, NJ, LA, SC, HI, OR, VT, MN, NV, CO and the countries of Argentina, Australia, Austria, Azerbaijan, Belgium, Brazil, Bulgaria, Canada, Chil
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2247-2023
- VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
Ongoing Class II Medical devices
- Recall started
- 7 December 2022
- Reason
- Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.
- Distribution
- US: FL, MS, NY, TN, TX, IL, MN, OH. OUS: Belgium, China, Estonia, France, Germany, Indonesia, Italy, Japan, Malaysia, Netherlands, Portugal, Sri Lanka, Switzerland, Thailand, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1006-2023, Z-1005-2023, Z-1007-2023
- FUSION Dual Pump Packs, REF: OPO73
- Veritas Advanced Infusion Packs, REF: VRT-AI
- Single-Use Packs, REF: OPO80
Ongoing Class II Medical devices
- Recall started
- 7 September 2022
- Reason
- Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation may have thrombogenic/toxic effect.
- Distribution
- Worldwide - US Nationwide distribution in the states of NC, TN, VA, OH, MO, MI, GA, OR, MO, SD, CO, OH, FL, NJ, TX, IL, WI and the countries of CROATIA, GERMANY, HUNGARY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0169-2023
- 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 cardi
Ongoing Class II Medical devices
- Recall started
- 1 September 2022
- Reason
- As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.
- Distribution
- Worldwide Distribution. US states of AL, AR, AZ, CA, CO, DE, FL, GA, HI, IL IN, KY LA, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, VA, and WA; Australia, Azerbaijan, Belgium, Brazil, Canada, Denmark, Egypt, Estonia, Finland, France, Germany, Hong Kong, India, Iraq, Ireland, Italy, Japan, Jordan, Kuwa
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0086-2023
- Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
Ongoing Class II Medical devices
- Recall started
- 6 April 2022
- Reason
- Potential breach in the sterility barrier for tray ring covers.
- Distribution
- Worlwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IL, IN, KS, MA, MD, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OR, PA, TN, TX, WA, WI and the countries of Chile, Indonesia, India, Japan, Malaysia, Philippines, Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1033-2022
- TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
Terminated Class II Medical devices
- Recall started
- 6 August 2021
- Terminated
- 6 March 2023
- Reason
- Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recommended endotoxin specification limit. Product was released in error based on the results of additional testing performed during the investigation into release testing nonconformance.
- Distribution
- U.S. Nationwide distribution in the state of IL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0028-2022
- 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 functio
Terminated Class II Medical devices
- Recall started
- 27 January 2021
- Terminated
- 9 November 2022
- Reason
- Due to the release of nonconforming Intraocular Lenses (IOLs).
- Distribution
- U.S. Nationwide distribution in the states of AL, AZ, CA, FL, GA, IL, LA, MI, MN, NC, NY, OH, PA, SC, TN, TX, UT and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1163-2021
- TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.
Terminated Class II Medical devices
- Recall started
- 3 December 2019
- Terminated
- 28 April 2021
- Reason
- Ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased postoperative intraocular pressure requiring additional intervention. Also, reports of clogging of phacoemulsion equipment tubing, which may lead to delay in the procedure or ocular injury.
- Distribution
- U.S.: CA, PA, NJ, GA, IL, MO, CO, TX, FL, AK, NY, HI, UT, LA, OH, IN, MA, NC, AZ, MI, NH, AL, TN, WA, MD, OR, VA, MS, MN, KY, AR, NV, WI, WV, SC, DE, ME, CT, ID, NM, VT, IA, OK, MT, NE, DC. OUS: DE, GB, DK, IT, NL, TR, AT, CH, FR, GR, ES, PT, FO, BE, GP, ZA, IE, HR, HU, IS, NO, SE, FI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0867-2020
- 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
Terminated Class II Medical devices
- Recall started
- 24 September 2018
- Reason
- Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including corneal incision enlargement.
- Distribution
- US Distribution to states of: NC, NV, TX, NY, UT, C, MN, NY, WA, NJ, OH, NV, CA and Internationally to: Australia and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1893-2019
- 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 be
Terminated Class II Medical devices
- Recall started
- 21 June 2018
- Terminated
- 28 April 2021
- Reason
- Expired intraocular lenses were distributed.
- Distribution
- US Nationwide distribution in the states of IN, MN, NC, NV, TX, and WA, WV. There was no foreign/military/government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0464-2019
- 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
Terminated Class II Medical devices
- Recall started
- 9 May 2018
- Terminated
- 13 January 2021
- Reason
- Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on the treatment overlay screen on the system GUI.
- Distribution
- US Distribution to states of: CO, GA, IL, MD including Puerto Rico and internationally to countries of: Austria and Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0066-2019
- 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 1
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.