---
title: "TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only — FDA record Z-2289-2023 | Is It on Recall"
description: "Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks."
url: https://isitonrecall.com/recall/fda-device-z-2289-2023-tecnis-eyhance-iol-ref-icb00-sterile-eo-rx-only/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only — FDA record Z-2289-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 6, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
- **Reason**: Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
- **Classification**: Class II
- **Recalling firm**: Johnson & Johnson Surgical Vision, Inc.
- **Quantity**: 61 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2289-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2289-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Aug 9, 2023
- **Recall initiation date**: Jul 6, 2023
- **Center classification date**: Aug 3, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2289-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Johnson & Johnson Surgical Vision Inc records](https://isitonrecall.com/brand/johnson-johnson-surgical-vision-inc/)