FDA Device recall Z-2289-2023

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

FDA Device
Class II
ongoing
Published 2023-08-09

On 2023-08-09 the FDA classified a Class II recall of TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only by Johnson And Johnson Surgical Vision, citing their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2289-2023
Classification	Class II
Status	ongoing
Initiated	2023-07-06
Published	2023-08-09
Last updated	2026-09-13 11:56 UTC
Company	Johnson And Johnson Surgical Vision
Distribution	n/a

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.

Identifiers

code_info	UDI-DI: N/A/ Serial Numbers: 8046642236, 8046652236, 8046662236, 8046672236, 8046682236, 8046692236, 8046702236, 80467… 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

code_info

UDI-DI: N/A/ Serial Numbers: 8046642236, 8046652236, 8046662236, 8046672236, 8046682236, 8046692236, 8046702236, 80467…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2289-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.