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.…
Read the official notice →- Date
- 2021-10-13
- Country
- United States
- Brand
- Johnson & Johnson Surgical Vision
- Product
- TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery…
- Classification
- Class II
- Units
- U.S. Nationwide distribution in the state of IL.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Johnson & Johnson Surgical Vision recalls
- 2023-08-09
USJohnson & 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 →
Other drugs & medical recalls in the United States
- 2021-10-13
- US
NOX MEDICAL recalls Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Error in the device firmware results in the inaccurate detection of device position.
FDA · DeviceNOX MEDICALUS Nationwide distribution in the states of OH, IL, GA, IA, CA, PA, NM, MI, SD.Official notice → - US
Contamac Solutions, Inc. recalls Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml…
Contact lens solution may contain foreign material
FDA · DeviceContamac Solutions, Inc.US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC,…Official notice → - US
Aesthetics Systems Usa Inc recalls Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue:…
FDA · DeviceAesthetics Systems Usa IncU.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA.Official notice → - US
Exactech, Inc. recalls OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b.…
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
FDA · DeviceExactech, Inc.Worldwide distribution - US Nationwide distribution and the countries of…Official notice → - US
Paltop Advanced Dental Solutions Ltd recalls Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical…
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified.…
FDA · DevicePaltop Advanced Dental Solutions LtdUS Nationwide distribution. No foreign distribution from US.Official notice → - US
GE Healthcare, LLC recalls Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).
FDA · DeviceGE Healthcare, LLCAR, IL, ME, MS, NE, NJ, NY, and TN Belgium, Canada, Costa Rica, France,…Official notice →