EVA NEXUS Ophthalmic Surgical System

510(k) K213467

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK213467	Date14 Jun 2022Cleared	StatusActive

6 recalls · 6 ongoing · FDA

3 recalls, same reason
- Ongoing Z-2322-2026 FDA Class II initiated 30 Apr 2026 on shared 510(k) K213467
- Ongoing Z-2324-2026 FDA Class II initiated 30 Apr 2026 on shared 510(k) K213467
- Ongoing Z-2323-2026 FDA Class II initiated 30 Apr 2026 on shared 510(k) K213467
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
3 recalls, same reason
- Ongoing Z-1333-2024 FDA Class II initiated 15 Jan 2024
- Ongoing Z-1332-2024 FDA Class II initiated 15 Jan 2024
- Ongoing Z-1331-2024 FDA Class II initiated 15 Jan 2024
When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)