CLASS II ONGOING Device recall · Reported 9 Aug 2023 · FDA Enforcement Report

Tecnis Eyhance IOL recalled by Johnson & Johnson Surgical

Johnson & Johnson Surgical Vision is recalling Tecnis Eyhance IOL. The recall was initiated on 6 Jul 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: N/A/ Serial Numbers: 8046642236, 8046652236, 8046662236, 8046672236, 8046682236, 8046692236, 8046702236, 8046712236, 8046722236, 8046732236, 8046742236, 8046752236, 8046762236, 8046772236, 8046782236, 8046792236, 8046802236, 8046812236, 8046822236, 8046832236, 8046842236, 8046852236, 8046862236, 8046872236, 8046882236, 8046892236, 8046902236, 8046912236, 8046922236, 8046932236, 8046942236, 8046952236, 8046962236, 8046972236, 8046982236, 8046992236, 8047002236, 8047012236, 8047022236, 8047032236, 8047042236, 8047052236, 8047062236, 8047072236, 8047082236, 8047102236, 8047112236, 8047122236, 8047132236, 8047142236, 8047152236, 8047162236, 8047172236, 8047182236, 8047192236, 8047202236, 8047212236, 8047222236, 8047232236, 8047242236, 8047252236

Quantity recalled61 units

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-2289-2023
FDA event ID: 92666
Recalling firm: Johnson & Johnson Surgical Vision, Irvine, CA
Classification: Class II
Status: Ongoing
Recall initiated: 6 Jul 2023
FDA classified: 3 Aug 2023
Reported: 9 Aug 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Contact Lenses & Eye Devices

Timeline

6 Jul 2023	Recall initiated by company
3 Aug 2023	Classified by FDA	+28 days
9 Aug 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.

Product as listed by the FDA

TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only

Where it was distributed

International distribution to the countries of China, India, Korea.

Questions about this recall

Why was it recalled?

Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.

Which lots are affected?

UDI-DI: N/A/ Serial Numbers: 8046642236, 8046652236, 8046662236, 8046672236, 8046682236, 8046692236, 8046702236, 8046712236, 8046722236, 8046732236, 8046742236, 8046752236, 8046762236, 8046772236, 8046782236, 8046792236, 8046802236, 8046812236, 8046822236, 8046832236, 8046842236, 8046852236, 8046862236, 8046872236, 8046882236, 8046892236, 8046902236, 8046912236, 8046922236, 8046932236, 8046942236, 8046952236, 8046962236, 8046972236, 8046982236, 8046992236, 8047002236, 8047012236, 8047022236, 8047032236, 8047042236, 8047052236, 8047062236, 8047072236, 8047082236, 8047102236, 8047112236, 8047122236, 8047132236, 8047142236, 8047152236, 8047162236, 8047172236, 8047182236, 8047192236, 8047202236, 8047212236, 8047222236, 8047232236, 8047242236, 8047252236

Where was it sold?

International distribution to the countries of China, India, Korea.

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.

Other products in this recall event

1 other product · FDA event 92666

This product is part of a recall event; the main page for the event is Tecnis Symfony, Extended Range of Vision IOL recalled.

Reported	Class	Recall	Company	Reason	Where
9 Aug 2023	CLASS II	Tecnis Symfony, Extended Range of Vision IOL recalled	Johnson & Johnson Surgical Vision	Other	CA

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