Home / Recalls / Johnson & Johnson Surgical Vision, Inc. / Z-2247-2023

Z-2247-2023 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
August 9, 2023
Initiation Date
May 30, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
148,941

Product Description

VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)

Reason for Recall

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 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

Worldwide - US Nationwide distribution including in the states of NC, OH, NY, IN, FL, TN, CA, PA, AZ, AL, TX, WA, WV, MS, GA, UT, KY, IA, MO, AR, DE, IL, WI, VA, NJ, LA, SC, HI, OR, VT, MN, NV, CO and the countries of Argentina, Australia, Austria, Azerbaijan, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Korea¿(South), Kuwait, Lebanon, Malaysia, Morocco, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela.

Code Information

All lots within their expiration date as of 5/29/2023. Part Number/UDI-DI/Lot: VRT-AI/05050474700901/60298931, 60302489, 60302939, 60302941, 60302953, 60302954, 60304170, 60304175, 60304176, 60305660, 60305661, 60305662, 60305665, 60306934, 60306935, 60306936, 60306940, 60306942, 60308193, 60309850, 60309844, 60309845, 60309853, 60314642, 60314676, 60314677, 60316112, 60351692, 60372490, 60372491, 60374175, 60374945, 60376930, 60378840, 60378842, 60378844, 60400795, 60401984, 60413115, 60413116, 60413117, 60414191, 60415077, 60415078, 60416304, 60420003, 60421952, 60425389, 60426314, 60426315, 60428217, 60428216, 60429442, 60433653, 60433654, 60433655, 60435921, 60435922, 60435923, 60437988, 60437989, 60440239, 60440240, 60442450, 60442451, 60442452, 60442453, 60442454, 60444535, 60446059, 60448847, 60448856, 60448857, 60376931, 60379976, 60429443. VRT-AF/05050474700895/60304172, 60304173, 60304174, 60305657, 60305658, 60305659, 60306930, 60306931, 60306932, 60306933, 60308189, 60308190, 60309848, 60309847, 60314640, 60314641, 60314674, 60314675, 60378839, 60420004, 60446054, 60446055

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-1006-2023 Class II — FUSION Dual Pump Packs, REF: OPO73 (December 7, 2022)
  • Z-1005-2023 Class II — Veritas Advanced Infusion Packs, REF: VRT-AI (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-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)