Veritas Advanced Infusion Packs. Used in ophthalmic procedures.

FDA Device Recall #Z-0086-2023 — Class II — September 1, 2022

Recall Summary

Recall Number Z-0086-2023
Classification Class II — Moderate risk
Date Initiated September 1, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Johnson & Johnson Surgical Vision, Inc.
Location Irvine, CA
Product Type Devices
Quantity 53,624 units

Product Description

Veritas Advanced Infusion Packs. Used in ophthalmic procedures.

Reason for Recall

As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.

Distribution Pattern

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, Kuwait, Morocco, Netherlands, New Zealand, Oman, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom

Lot / Code Information

Part Number: VRT-AI UDI-DI Code: 05050474700901 Lot Numbers: 60316112 60330206 60330248 60341105 60341106 60341107 60342401 60343412 60343413 60351691 60352993 60352994 60352995 60352996 60352997 60352998 60352999 60353436 60353443 60353444 60353445 60353446 60353447 60353448 60353449 60353450 60353451 60353452 60353453 60353772 60353811 60353812 60353813 60353814 60353815 60354982 60355023 60355024 60355025 60355026 60355027 60355330 60355335 60355972 60360065 60360066 60362043 60362044 60362435 60362436 60364566 60369607 60369608 60369609 60381689

Other Recalls from Johnson & Johnson Surgical Vision, Inc.

Recall # Classification Product Date
Z-1755-2024 Class II Johnson & Johnson VISION Reusable LAMINAR High ... Mar 14, 2024
Z-0735-2024 Class II TECNIS Toric II OptiBlue IOL Models ZCW Dec 12, 2023
Z-2288-2023 Class II TECNIS Symfony, Extended Range of Vision IOL, R... Jul 6, 2023
Z-2289-2023 Class II TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx ... Jul 6, 2023
Z-2247-2023 Class II VERITAS Advanced Infusion Packs (VRT-AI) and VE... May 30, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.