CLASS II Device recall · Reported 10 Mar 2021 · FDA Enforcement Report

Tecnis Toric 1-Piece IOL recalled by Johnson & Johnson Surgical

Johnson & Johnson Surgical Vision is recalling Tecnis Toric 1-Piece IOL, distributed nationwide in the US. The recall was initiated on 27 Jan 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: ZCT150 UDI/GTIN Codes: (01)05050474552210(17)221123(21)8144121847 5050474552210 Lot Number: 8144121847

Quantity recalled27 lenses

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-1163-2021
FDA event ID: 87320
Recalling firm: Johnson & Johnson Surgical Vision, Santa Ana, CA
Classification: Class II
Status: Terminated
Recall initiated: 27 Jan 2021
FDA classified: 3 Mar 2021
Reported: 10 Mar 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Contact Lenses & Eye Devices

Timeline

27 Jan 2021	Recall initiated by company
3 Mar 2021	Classified by FDA	+35 days
10 Mar 2021	Published in enforcement report	+7 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 the release of nonconforming Intraocular Lenses (IOLs).

Product as listed by the FDA

TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.

Where it was distributed

U.S. Nationwide distribution in the states of AL, AZ, CA, FL, GA, IL, LA, MI, MN, NC, NY, OH, PA, SC, TN, TX, UT and WA.

Nationwide Alabama Arizona California Florida Georgia Illinois Louisiana Michigan Minnesota North Carolina New York Ohio Pennsylvania South Carolina Tennessee Texas Utah Washington

Questions about this recall

Why was it recalled?

Due to the release of nonconforming Intraocular Lenses (IOLs).

Which lots are affected?

Model Number: ZCT150 UDI/GTIN Codes: (01)05050474552210(17)221123(21)8144121847 5050474552210 Lot Number: 8144121847

Where was it sold?

U.S. Nationwide distribution in the states of AL, AZ, CA, FL, GA, IL, LA, MI, MN, NC, NY, OH, PA, SC, TN, TX, UT and WA.

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

All 18

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9 Sep 2026Device	CLASS II	Healon EndoCoat PRO recalled by Johnson & Johnson Surgical	Johnson & Johnson Surgical Vision	Other	Nationwide
8 May 2024Device	CLASS II	Johnson & Johnson Vision Reusable Laminar High Flow recalled	Johnson & Johnson Surgical Vision	Other	Nationwide
24 Jan 2024Device	CLASS II	Tecnis Toric II OptiBlue IOL recalled by Johnson & Johnson Surgical	Johnson & Johnson Surgical Vision	Potency & Assay	CA
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

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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