Johnson & Johnson Surgical Vision, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1007-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Single-Use Packs, REF: OPO80

Product Classification:

Class II

Date Initiated: December 7, 2022

Date Posted: February 1, 2023

Recall Number: Z-1007-2023

Event ID: 91290

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.

Status: Ongoing

Product Quantity: 384

Code Information:

UDI-DI/Lot: 05050474573352/60326033

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated