# FDA recall Z-0981-2018

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

## Product

NovaKone Daily Wear Soft contact; Catalog Number: AONKS54    Product Usage:  The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) in aphakic and not aphakic persons with otherwise nondiseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.

## 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-0981-2018
- **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-0981-2018

## Citation

> AI Analytics. FDA recall Z-0981-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0981-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*