Johnson & Johnson Surgical Vision, Inc. recalls Single-Use Packs, REF: OPO80

Recall date

December 7, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1007-2023

FDA classification

Class II

Brand / firm

Johnson & Johnson Surgical Vision, Inc.

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Single-Use Packs, REF: OPO80