# FDA recall Z-0982-2018

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

## Product

NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54    Product Usage:  The NOVAKONE TORIC lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with otherwise non-diseased eyes and who possess 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-0982-2018
- **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-0982-2018

## Citation

> AI Analytics. FDA recall Z-0982-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0982-2018. Source: US FDA. Licensed CC0.

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