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EVA NEXUS™ Posterior 23G TDC Pack 9310.23G01-00

by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

6 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08717872034737 UDI-DI Date20 Feb 2024ListedStatusListed GUDID: in commercial distribution

Recalls

6 recalls · 6 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-2322-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2324-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2323-2026 FDA Class II initiated 30 Apr 2026

    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 on shared 510(k) K213467
    • Ongoing Z-1332-2024 FDA Class II initiated 15 Jan 2024 on shared 510(k) K213467
    • Ongoing Z-1331-2024 FDA Class II initiated 15 Jan 2024 on shared 510(k) K213467

    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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
EVA NEXUS™ Posterior 23G TDC Pack
Generic Name
Ophthalmic surgical procedure kit, non-medicated, single-use
Model / Ref / Catalog
9310.23G01-00
Primary DI / UDI-DI
08717872034737
510(k) Number
FDA Product Code
HQE
GMDN Term
Ophthalmic surgical procedure kit, non-medicated, single-use
Device Class
Class II
Regulation Number
886.4150
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ophthalmic surgical procedure kit, non-medicated, single-use

Cleared under the same submission (K213467)

Show all (12)

Other devices from D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

See all devices from D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No