Home / Recalls / Johnson & Johnson Surgical Vision, Inc. / Z-0086-2023

Z-0086-2023 Class II Ongoing

Recalled by Johnson & Johnson Surgical Vision, Inc. — Irvine, CA

FDA device recall Z-0086-2023 was initiated by Johnson & Johnson Surgical Vision, Inc. on September 1, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 53,624 units.

Recall Details

Product Type
Devices
Report Date
October 19, 2022
Initiation Date
September 1, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product 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

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 by Johnson & Johnson Surgical Vision, Inc.

  • Z-1755-2024 Class II — Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test C (March 14, 2024)
  • Z-0735-2024 Class II — TECNIS Toric II OptiBlue IOL Models ZCW (December 12, 2023)
  • Z-2288-2023 Class II — TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only (July 6, 2023)
  • Z-2289-2023 Class II — TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only (July 6, 2023)
  • Z-2247-2023 Class II — VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VR (May 30, 2023)
  • Z-1005-2023 Class II — Veritas Advanced Infusion Packs, REF: VRT-AI (December 7, 2022)
  • Z-1006-2023 Class II — FUSION Dual Pump Packs, REF: OPO73 (December 7, 2022)
  • Z-1007-2023 Class II — Single-Use Packs, REF: OPO80 (December 7, 2022)
  • Z-0169-2023 Class II — THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. (September 7, 2022)
  • Z-1033-2022 Class II — TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only, (April 6, 2022)

FDA data resources