NovaKone Daily Wear Soft contact — Class II medical device recall Z-0981-2018
Terminated recall by Alden Optical, reported 2018-03-21, distributed nationwide. Contact lenses lack sterility assurance.
| Recall number | Z-0981-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alden Optical, Lancaster, NY, United States |
| Recall initiated | 2017-11-03 |
| Classified | 2018-03-13 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2018-06-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 3 |
| Reason classes | sterility |
| Model numbers | AONKS54 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0981-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.