FDA Device recall Z-0982-2018
NovaKone Toric Daily Wear Soft contact
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of NovaKone Toric Daily Wear Soft contact by Alden Optical, citing contact lenses lack sterility assurance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0982-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-03 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Alden Optical |
| Distribution | US |
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
Contact lenses lack sterility assurance.
Identifiers
| code_info | AZ150410 AZ125410 AZ143310 AZ143320 AZ119610 AZ139910 AZ139920 AZ119810 AZ119820 AZ147210 AZ147220 AZ155820…AZ150410 AZ125410 AZ143310 AZ143320 AZ119610 AZ139910 AZ139920 AZ119810 AZ119820 AZ147210 AZ147220 AZ155820 AZ155910 AZ155920 AZ152010 AZ152020 AZ144710 AZ144720 AZ153620 AZ150710 AZ121910 AZ121920 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0982-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.