Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

FUSION Dual Pump Packs Recalled by Johnson & Johnson Surgical Vision, Inc. Due to Weld protrusion/physical gap between the housing and phaco...

Date: December 7, 2022
Company: Johnson & Johnson Surgical Vision, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Johnson & Johnson Surgical Vision, Inc. directly.

Affected Products

FUSION Dual Pump Packs, REF: OPO73

Quantity: 7644

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 8 states: FL, IL, MN, MS, NY, OH, TN, TX

Affected (8 states)Not affected

About Johnson & Johnson Surgical Vision, Inc.

Johnson & Johnson Surgical Vision, Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report