Johnson & Johnson Surgical Vision recalls
10 official recalls and safety alerts involving Johnson & Johnson Surgical Vision since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Johnson & Johnson Surgical Vision or the relevant agency.
- 2026-09-09
USJohnson & Johnson Surgical Vision, Inc. recalls HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF:…
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…
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.Worldwide - US Nationwide distribution including in the states of PA, AL, AZ,…Official notice →- 2024-05-08
- US
Johnson & Johnson Surgical Vision, Inc. recalls Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The…
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…
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.U.S. Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, LA, MA,…Official notice → - 2024-01-24
- US
Johnson & Johnson Surgical Vision, Inc. recalls TECNIS Toric II OptiBlue IOL Models ZCW
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.
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.International distribution to the country of Japan.Official notice → - 2023-08-09
- US
Johnson & Johnson Surgical Vision, Inc. recalls TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only
Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.International distribution to the countries of China, India, Korea.Official notice → - US
Johnson & Johnson Surgical Vision, Inc. recalls VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
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…
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.Worldwide - US Nationwide distribution including in the states of NC, OH, NY,…Official notice → - 2023-02-01
- US
Johnson & Johnson Surgical Vision, Inc. recalls FUSION Dual Pump Packs, REF: OPO73
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…
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.US: FL, MS, NY, TN, TX, IL, MN, OH. OUS: Belgium, China, Estonia, France,…Official notice → - 2022-11-09
- US
Johnson & Johnson Surgical Vision, Inc. recalls THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac…
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…
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.Worldwide - US Nationwide distribution in the states of NC, TN, VA, OH, MO,…Official notice → - 2022-10-19
- US
Johnson & Johnson Surgical Vision, Inc. recalls Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.Worldwide Distribution. US states of AL, AR, AZ, CA, CO, DE, FL, GA, HI, IL…Official notice → - 2022-05-11
- US
Johnson & Johnson Surgical Vision Inc recalls TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
Potential breach in the sterility barrier for tray ring covers.
FDA · DeviceJohnson & Johnson Surgical Vision IncWorlwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice → - 2021-10-13
- US
Johnson & Johnson Surgical Vision Inc recalls TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS…
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.…
FDA · DeviceJohnson & Johnson Surgical Vision IncU.S. Nationwide distribution in the state of IL.Official notice →