# FDA recall Z-1007-2023

> **Johnson & Johnson Surgical Vision, Inc.** · Class II · device recall initiated 2022-12-07.

## Product

Single-Use Packs, REF: OPO80

## 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.

## 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

## Key facts

- **Recall number:** Z-1007-2023
- **Recalling firm:** Johnson & Johnson Surgical Vision, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-07
- **Report date:** 2023-02-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1007-2023

## Citation

> AI Analytics. FDA recall Z-1007-2023. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-1007-2023. Source: US FDA. Licensed CC0.

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