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FUSION Dual Pump Packs, REF: OPO73

FDA Recall #Z-1006-2023 — Class II — December 7, 2022

Recall #Z-1006-2023 Date: December 7, 2022 Classification: Class II Status: Ongoing

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.

Recalling Firm

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

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

7644

Distribution

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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