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Clareon CNA0T3

by Alcon Laboratories, Inc. 34 variants

Ref CNA0T3.060

Clareon CNA0T3 (CNA0T3.060) is a device classified as Class IIb in the EU and Class III in the US made by Alcon Laboratories, Inc., registered in EUDAMED on 10 Aug 2026 (Basic UDI-DI 038065GMN000142GY) with CE/MDR certificate G70 020895 0412 valid until 4 Dec 2029 and listed in FDA GUDID since 24 Nov 2025 (UDI-DI 00380652398503), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038065GMN000142GY Basic UDI-DI 00380652398503UDI-DIDate10 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380652398503 UDI-DI Date24 Nov 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038065GMN000142GY registered 10 Aug 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00380652398503 listed 24 Nov 2025 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 020895 0412 Withdrawn

    Technical documentation EU MDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    11 Jun 2026
    Expires
    4 Dec 2029
    Reason
    Transferred to other nb

Timeline

4 dated events

  1. Listed FDA GUDID 00380652398503
  2. Certificate issued EUDAMED G70 020895 0412
  3. Registered EUDAMED 038065GMN000142GY
  4. Certificate expires EUDAMED G70 020895 0412

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Clareon
Generic name
Posterior-chamber intraocular lens, pseudophakic
Device name
Clareon Toric Aspheric IOL AutonoMe Pre-Loaded Delivery System CNA0T2-CNA0T9
Model / Ref / Catalog
CNA0T3.060, CNA0T3
Primary DI / UDI-DI
00380652398503
Basic UDI-DI
038065GMN000142GY
FDA product code
HQL
EMDN code
P030102090301 IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC
GMDN term
Posterior-chamber intraocular lens, pseudophakic
Device class
Class IIb EUDAMED
Class III GUDID
Regulation number
886.3600
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
CNA0T3.060
GUDID
CNA0T3
Device classEUDAMED
Class IIb
GUDID
Class III

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC.

Other devices from Alcon Laboratories, Inc.

See all devices from Alcon Laboratories, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Contains animal tissues or cells
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)