Device recall: NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE SPHERICAL lens is indicated for da

FDA enforcement event 79377 · Class II · initiated 3 Nov 2017 · status Terminated · terminated 19 Jun 2018

DeviceVoluntary: Firm initiated11 product recordsLancaster, NY

Alden Optical (Lancaster, NY) initiated this device recall on 3 Nov 2017; FDA lists 11 product records under event 79377, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 19 Jun 2018. Initiation: voluntary: firm initiated. Alden Optical has 2 enforcement events on this register, with a median of 11 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Alden Optical, Lancaster, NY.

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."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0981-2018	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…	3	Class II	Terminated	21 Mar 2018
Z-0982-2018	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…	33	Class II	Terminated	21 Mar 2018
Z-0983-2018	Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 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…	4	Class II	Terminated	21 Mar 2018
Z-0984-2018	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…	23	Class II	Terminated	21 Mar 2018
Z-0985-2018	Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 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…	2	Class II	Terminated	21 Mar 2018
Z-0986-2018	Alden HP59 Sphere Daily Wear Soft contact; Catalog Number: AOHPS59 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…	3	Class II	Terminated	21 Mar 2018
Z-0987-2018	Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product Usage: The ALDEN TORIC 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) and/or possesses refractive astigmatism not…	56	Class II	Terminated	21 Mar 2018
Z-0988-2018	Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54 Product Usage: The ALDEN TORIC 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) and/or possesses refractive astigmatism not…	14	Class II	Terminated	21 Mar 2018
Z-0989-2018	Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 Product Usage: The ALDEN TORIC 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) and/or possesses refractive astigmatism…	1	Class II	Terminated	21 Mar 2018
Z-0990-2018	Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product Usage: The ALDEN TORIC 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) and/or possesses refractive astigmatism not…	5	Class II	Terminated	21 Mar 2018
Z-0991-2018	ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 Product Usage: The ALDEN TORIC 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) and/or possesses refractive astigmatism…	4	Class II	Terminated	21 Mar 2018

Context

93%of 2017 device events are Class II1,091 events that year

11product records in this eventfirm median: 11

2events on this register for the firm

Other enforcement events for Alden Optical

Initiated	Product (first record)	Type	Class	Records
3 Jul 2018	Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Fron	Device	Class III	2

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Contact lenses lack sterility assurance."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "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."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 19 Jun 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.