# FDA recall Z-0229-2022

> **Beaver Visitec International, Inc.** · Class II · device recall initiated 2021-10-08.

## Product

bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component REF# 58000572  REF#: 373809

## Reason for recall

Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades

## Distribution

Nationwide Foreign: Australia Austria  France  Germany  Netherlands  Spain Japan Russia  South Africa UK

## Key facts

- **Recall number:** Z-0229-2022
- **Recalling firm:** Beaver Visitec International, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-08
- **Report date:** 2021-11-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0229-2022

## Citation

> AI Analytics. FDA recall Z-0229-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0229-2022. Source: US FDA. Licensed CC0.

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