FDA Device recall Z-2288-2023
TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, 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 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
| Agency | FDA Device |
|---|---|
| Recall number | Z-2288-2023 |
| 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 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
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