CLASS II Device recall · Reported 21 Mar 2018 · FDA Enforcement Report
NovaKone Toric Daily Wear Soft contact recalled by Alden Optical
Alden Optical is recalling NovaKone Toric Daily Wear Soft contact, distributed nationwide in the US. The recall was initiated on 3 Nov 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0982-2018
- FDA event ID
- 79377
- Recalling firm
- Alden Optical, Lancaster, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Nov 2017
- FDA classified
- 13 Mar 2018
- Reported
- 21 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 3 Nov 2017 | Recall initiated by company | |
| 13 Mar 2018 | Classified by FDA | +130 days |
| 21 Mar 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Contact lenses lack sterility assurance.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide CaliforniaFloridaGeorgiaIdahoIllinoisIndianaKansasKentuckyMarylandMichiganMissouriMississippiNorth CarolinaNew JerseyNew MexicoNevadaNew YorkOhioOregonPennsylvania
Questions about this recall
Why was it recalled?
Contact lenses lack sterility assurance.
Which lots are affected?
AZ150410 AZ125410 AZ143310 AZ143320 AZ119610 AZ139910 AZ139920 AZ119810 AZ119820 AZ147210 AZ147220 AZ155820 AZ155910 AZ155920 AZ152010 AZ152020 AZ144710 AZ144720 AZ153620 AZ150710 AZ121910 AZ121920
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 79377More recalls from Alden Optical
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Zen RC Toric-Gas permeable contact lenses for Daily Wear recalled | Alden Optical | Other | 13 states |
| Device | CLASS III | Zenlens Toric-Gas Permeable Contact lenses for Daily Wear recalled | Alden Optical | Other | 13 states |
| Device | CLASS II | Astera Multifocal Toric Daily Wear Soft contact recalled | Alden Optical | Sterility | Nationwide |
| Device | CLASS II | Alden HP59 Sphere Daily Wear Soft contact recalled by Alden Optical | Alden Optical | Sterility | Nationwide |
| Device | CLASS II | Alden HP54 Sphere Daily Wear Soft contact recalled by Alden Optical | Alden Optical | Sterility | Nationwide |
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| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |