RecallRadar

FDA Device recall Z-2288-2023

TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only

On 2023-08-09 the FDA classified a Class II recall of TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, 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

AgencyFDA Device
Recall numberZ-2288-2023
ClassificationClass II
Statusongoing
Initiated2023-07-06
Published2023-08-09
Last updated2026-09-13 11:56 UTC
CompanyJohnson And Johnson Surgical Vision
Distributionn/a

Product

TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, 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: 5050474579163/ Serial Numbers: 8210142244, 8210152244, 8210162244, 8210172244, 8210182244, 8210192244, 8210202…UDI-DI: 5050474579163/ Serial Numbers: 8210142244, 8210152244, 8210162244, 8210172244, 8210182244, 8210192244, 8210202244, 8210212244, 8210222244, 8210232244, 8210242244, 8210252244, 8210262244, 8210272244, 8210282244, 8210292244, 8210302244, 8210312244, 8210322244, 8210332244, 8210342244, 8210352244, 8210362244, 8210372244, 8210382244, 8210392244, 8210402244, 8210412244, 8210422244, 8210432244, 8210442244, 8210452244, 8210462244, 8210472244, 8210482244, 8210492244, 8210502244, 8210512244, 8210522244, 8210532244, 8210542244, 8210552244,

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-2288-2023%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.