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Tecnis IOL ZXR00

by Johnson & Johnson Surgical Vision, Inc. 59 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number05050474579026 UDI-DI Date2 Aug 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Tecnis IOL
Generic name
Posterior-chamber intraocular lens, pseudophakic
Model / Ref / Catalog
ZXR00, ZXR00U0165
Primary DI / UDI-DI
05050474579026
FDA product code
POE
GMDN term
Posterior-chamber intraocular lens, pseudophakic
Device class
Class III
Regulation number
886.3600
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 13 Millimeter

Related devices

Category: Posterior-chamber intraocular lens, pseudophakic

Other devices from Johnson & Johnson Surgical Vision, Inc.

See all devices from Johnson & Johnson Surgical Vision, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Serial number
  • Expiration date

Other properties (9)

  • Sterilise before use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Lot / batch number: No
  • Manufacturing date: No