Z-0982-2018Class II

NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54

Name: Z-0982-2018 NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54
Creator: Alden Optical
Published: 2017-11-03
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2017-11-03 / Terminated / root cause: manufacturing process

FDA source

Alden Optical began a recall of NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage: The NOVAKONE TORIC lens is indicated for daily wear for persons requiring... on 2017-11-03. FDA classified it as Class II and gives the reason as "Contact lenses lack sterility assurance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0982-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-03
Posted: 2018-03-13
Terminated: 2018-06-19
Recalling firm: Bausch & Lomb Incorporated
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.
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: Contact lenses lack sterility assurance.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Consignees were initially called and told over the phone not to further distribute the contact lenses. For two consignees whose patients could not be reached by phone, a letter was sent. The consignee letter states the specific product and lot should not be further distributed due to the lack of sterility assurance. A business reply card was provided with the letter and contacts should be returned to the manufacturer using a label provided by the firm.
Quantity in commerce: 33
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.
Product codes and lots: AZ150410 AZ125410 AZ143310 AZ143320 AZ119610 AZ139910 AZ139920 AZ119810 AZ119820 AZ147210 AZ147220 AZ155820 AZ155910 AZ155920 AZ152010 AZ152020 AZ144710 AZ144720 AZ153620 AZ150710 AZ121910 AZ121920

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0982-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0981-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0982-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0983-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0984-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0985-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0986-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0987-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0988-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0989-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0990-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0991-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13

Product code LPL

K102557Class IINovakone Spherical and Toric LensesAlden Optical Labs., Inc. / cleared 2011-04-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)