# FDA recall Z-0991-2018

> **Alden Optical** · Class II · device recall initiated 2017-11-03.

## Product

ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54    Product Usage:  The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/or possesses refractive astigmatism not exceeding 10 Diopters.

## Reason for recall

Contact lenses lack sterility assurance.

## Distribution

Worldwide Distribution - US Nationwide in the states:of CA, FL, GA, ID, IL, IN, KS, KY, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, TX, VA, WI, WY and the country of Canada.

## Key facts

- **Recall number:** Z-0991-2018
- **Recalling firm:** Alden Optical
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-03
- **Report date:** 2018-03-21
- **Termination date:** 2018-06-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lancaster, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0991-2018

## Citation

> AI Analytics. FDA recall Z-0991-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0991-2018. Source: US FDA. Licensed CC0.

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