Home / Recalls / Johnson & Johnson Surgical Vision, Inc. / Z-1006-2023

Z-1006-2023 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
February 1, 2023
Initiation Date
December 7, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7644

Product Description

FUSION Dual Pump Packs, REF: OPO73

Reason for Recall

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 Pattern

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

Code Information

UDI-DI/Lots: 15050474602080/60373238, 60394037, 60308197

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-2289-2023 Class II — TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only (July 6, 2023)
  • Z-2288-2023 Class II — TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, 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-1007-2023 Class II — Single-Use Packs, REF: OPO80 (December 7, 2022)
  • Z-1005-2023 Class II — Veritas Advanced Infusion Packs, REF: VRT-AI (December 7, 2022)
  • Z-0169-2023 Class II — THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. (September 7, 2022)
  • Z-0086-2023 Class II — Veritas Advanced Infusion Packs. Used in ophthalmic procedures. (September 1, 2022)
  • Z-1033-2022 Class II — TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only, (April 6, 2022)