CLASS II Device recall · Reported 25 Dec 2019 · FDA Enforcement Report

Tekia Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses recalled

Tekia is recalling Tekia Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses. The recall was initiated on 9 Nov 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes36 recalled serial numbers from Lot 522-003: U12220229, U12220230, U12220231, U12220232, U12220233, U12220234, U12220235, U12220236, U12220237, V01110221, V01110222, V01110223, V01110224, V02200066, V02200067, V02200068, V02200069, V02200070, V02200071, V03190037, V03190038, V04090143, V04090144, V04090145, V04090146, V04090147, V04090148, V04090149, V04090150, V04090151, V04090152, V01080056, V01080057, V03290055, V03290056, and V05020831. The remaining 45 IOL serial numbers were past expiry and not recalled.

Quantity recalled81 IOLs were distributed but only 36 within expiry were recalled

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-0694-2020
FDA event ID: 83903
Recalling firm: Tekia, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 9 Nov 2018
FDA classified: 17 Dec 2019
Reported: 25 Dec 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Contact Lenses & Eye Devices

Timeline

9 Nov 2018	Recall initiated by company
17 Dec 2019	Classified by FDA	+403 days
25 Dec 2019	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

A limited number of lenses may be mislabeled with the incorrect diopter power.

Product as listed by the FDA

TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.

Where it was distributed

There was no U.S. distribution. Foreign distribution was made to Iran, Korea, Luxembourg, and Vietnam.

Questions about this recall

Is Tekia Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses recalled?

Yes. Tekia recalled Tekia Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses on 9 Nov 2018. The recall is Class II and its status is Terminated. Recall number Z-0694-2020.

Why was it recalled?

A limited number of lenses may be mislabeled with the incorrect diopter power.

Which lots are affected?

36 recalled serial numbers from Lot 522-003: U12220229, U12220230, U12220231, U12220232, U12220233, U12220234, U12220235, U12220236, U12220237, V01110221, V01110222, V01110223, V01110224, V02200066, V02200067, V02200068, V02200069, V02200070, V02200071, V03190037, V03190038, V04090143, V04090144, V04090145, V04090146, V04090147, V04090148, V04090149, V04090150, V04090151, V04090152, V01080056, V01080057, V03290055, V03290056, and V05020831. The remaining 45 IOL serial numbers were past expiry and not recalled.

Where was it sold?

There was no U.S. distribution. Foreign distribution was made to Iran, Korea, Luxembourg, and Vietnam.

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.

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Reported	Class	Recall	Company	Reason	Where
18 Nov 2015Device	CLASS II	Single Piece Hydrophilic Acrylic Intraocular Lenses recalled by Tekia	Tekia	Other	Nationwide

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