# FDA recall Z-0405-2022

> **Beaver Visitec International, Inc.** · Class II · device recall initiated 2021-11-17.

## Product

Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2

## Reason for recall

Kit packaging may have small holes compromising product sterility

## Distribution

CA, CO, LA, MA, MD, ND, PA, TN, UT

## Key facts

- **Recall number:** Z-0405-2022
- **Recalling firm:** Beaver Visitec International, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-11-17
- **Report date:** 2021-12-29

- **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-0405-2022

## Citation

> AI Analytics. FDA recall Z-0405-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0405-2022. Source: US FDA. Licensed CC0.

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