# FDA recall Z-0984-2018

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

## Product

Alden HP49 Sphere Daily Wear Soft contact; Catalog Number: AOHPS49        Product Usage:  The ALDEN SPHERE 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). 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-0984-2018
- **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-0984-2018

## Citation

> AI Analytics. FDA recall Z-0984-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0984-2018. Source: US FDA. Licensed CC0.

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