# FDA recall Z-0071-2018

> **Aaren Scientific Inc.** · Class II · device recall initiated 2017-09-01.

## Product

AERO IOL Injection System containing 10  Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx.  The firm name on the label is Aaren Scientific Inc., Ontario, CA.  Used to fold and insert the firm's IOL's.

## Reason for recall

The recommended storage temperature on the label is incorrect.

## Distribution

Nationwide distribution including Puerto Rico.

## Key facts

- **Recall number:** Z-0071-2018
- **Recalling firm:** Aaren Scientific Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-01
- **Report date:** 2017-11-15
- **Termination date:** 2018-05-01

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0071-2018

## Citation

> AI Analytics. FDA recall Z-0071-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0071-2018. Source: US FDA. Licensed CC0.

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