CLASS II ONGOING Device recall · Reported 24 Jan 2024 · FDA Enforcement Report

Tecnis Toric II OptiBlue IOL recalled by Johnson & Johnson Surgical

Johnson & Johnson Surgical Vision is recalling Tecnis Toric II OptiBlue IOL. The recall was initiated on 12 Dec 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Numbers: ZCW375 UDI code: N/A (not distributed in the U.S.) Serial Numbers: 3473902107 3473912107 3473922107 3473932107 3473942107 3473952107 3473962107 3473972107 3474002107 3474012107 3474022107 3474072107 3474082107 3474092107 3474102107 3474112107 3474122107 3474132107 3474152107 3474162107 3474172107 3474182107 3474192107 3474202107 3474222107 3474232107 3474242107 3474252107 3474262107 3474282107 3474292107 3474312107 3474322107 3474332107 3474342107 3474352107

Quantity recalled36

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-0735-2024
FDA event ID: 93523
Recalling firm: Johnson & Johnson Surgical Vision, Irvine, CA
Classification: Class II
Status: Ongoing
Recall initiated: 12 Dec 2023
FDA classified: 16 Jan 2024
Reported: 24 Jan 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Contact Lenses & Eye Devices

Timeline

12 Dec 2023	Recall initiated by company
16 Jan 2024	Classified by FDA	+35 days
24 Jan 2024	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

Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

TECNIS Toric II OptiBlue IOL Models ZCW

Where it was distributed

International distribution to the country of Japan.

Questions about this recall

Why was it recalled?

Which lots are affected?

Model Numbers: ZCW375 UDI code: N/A (not distributed in the U.S.) Serial Numbers: 3473902107 3473912107 3473922107 3473932107 3473942107 3473952107 3473962107 3473972107 3474002107 3474012107 3474022107 3474072107 3474082107 3474092107 3474102107 3474112107 3474122107 3474132107 3474152107 3474162107 3474172107 3474182107 3474192107 3474202107 3474222107 3474232107 3474242107 3474252107 3474262107 3474282107 3474292107 3474312107 3474322107 3474332107 3474342107 3474352107

Where was it sold?

International distribution to the country of Japan.

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.

More recalls from Johnson & Johnson Surgical Vision

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9 Aug 2023Device	CLASS II	Tecnis Eyhance IOL recalled by Johnson & Johnson Surgical	Johnson & Johnson Surgical Vision	Other	CA
9 Aug 2023Device	CLASS II	Tecnis Symfony, Extended Range of Vision IOL recalled	Johnson & Johnson Surgical Vision	Other	CA
9 Aug 2023Device	CLASS II	Veritas Advanced Infusion Packs (Vrt-ai) recalled	Johnson & Johnson Surgical Vision	Device Malfunction	Nationwide

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1 Oct 2025Device	CLASS II	Sofmed Breathables, (stenfilcon A) contact lens recalled by CooperVision	CooperVision	Sterility	Nationwide
1 Oct 2025Device	CLASS II	Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled	CooperVision	Sterility	Nationwide
1 Oct 2025Device	CLASS II	MyDay Toric, stenfilcon A) Contact Lens recalled by CooperVision	CooperVision	Sterility	Nationwide