CLASS II Device recall · Reported 21 Mar 2018 · FDA Enforcement Report

Alden HP54 Toric Daily Wear Soft contact recalled by Alden Optical

Alden Optical is recalling Alden HP54 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

Lot, batch or date codesAZ150620 AZ159220 AZ156710 AZ156720

Quantity recalled14

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-0988-2018
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

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 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 California Florida Georgia Idaho Illinois Indiana Kansas Kentucky Maryland Michigan Missouri Mississippi North Carolina New Jersey New Mexico Nevada New York Ohio Oregon Pennsylvania

Questions about this recall

Is Alden HP54 Toric Daily Wear Soft contact recalled?

Yes. Alden Optical recalled Alden HP54 Toric Daily Wear Soft contact on 3 Nov 2017. The recall is Class II and its status is Terminated. Recall number Z-0988-2018.

Why was it recalled?

Contact lenses lack sterility assurance.

Which lots are affected?

AZ150620 AZ159220 AZ156710 AZ156720

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Alden Optical

All 13

Reported	Class	Recall	Company	Reason	Where
12 Sep 2018Device	CLASS III	Zen RC Toric-Gas permeable contact lenses for Daily Wear recalled	Alden Optical	Other	13 states
12 Sep 2018Device	CLASS III	Zenlens Toric-Gas Permeable Contact lenses for Daily Wear recalled	Alden Optical	Other	13 states
21 Mar 2018Device	CLASS II	Astera Multifocal Toric Daily Wear Soft contact recalled	Alden Optical	Sterility	Nationwide
21 Mar 2018Device	CLASS II	Alden HP59 Sphere Daily Wear Soft contact recalled by Alden Optical	Alden Optical	Sterility	Nationwide
21 Mar 2018Device	CLASS II	Alden HP54 Sphere Daily Wear Soft contact recalled by Alden Optical	Alden Optical	Sterility	Nationwide

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