Recall Z-0086-2023— Johnson & Johnson Surgical Vision, Inc.

Name: FDA recall Z-0086-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-01

Class II · Ongoing

Class II FDA medical device recall by Johnson & Johnson Surgical Vision, Inc., initiated 2022-09-01. It names one FDA 510(k) clearance: K203060. Product: Veritas Advanced Infusion Packs. Used in ophthalmic procedures.. Reason: As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue..

Recalling firm: Johnson & Johnson Surgical Vision, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-09-01
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K203060 — VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote ControlJohnson & Johnson Surgical Vision, Inc.·cleared 2021-03-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.