Skip to content

Acrysof Ultrasert AU00T0

by Alcon Laboratories, Inc. 43 variants

Ref AU00T0.080

Acrysof Ultrasert AU00T0 (AU00T0.080) 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 29 Oct 2026 (Basic UDI-DI B-00380652358033) and listed in FDA GUDID since 24 Nov 2015 (UDI-DI 00380652358033), active as of 7 Nov 2026.

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

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00380652358033 Basic UDI-DI 00380652358033UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380652358033 UDI-DI Date24 Nov 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00380652358033 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00380652358033 listed 24 Nov 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380652358033
  2. Registered EUDAMED B-00380652358033

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
AcrySof EUDAMED
Acrysof Ultrasert GUDID
Generic name
Posterior-chamber intraocular lens, pseudophakic
Device name
UltraSert with AcrySof IQ Aspheric Natural IOL
Model / Ref / Catalog
AU00T0.080, AU00T0
Primary DI / UDI-DI
00380652358033
Basic UDI-DI
B-00380652358033
FDA product code
HQL
EMDN code
P030102090201 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
GMDN term
Posterior-chamber intraocular lens, pseudophakic
Device class
Class IIb EUDAMED
Class III GUDID
Regulation number
886.3600
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AU00T0.080
GUDID
AU00T0
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.

Related devices

Category: Posterior-chamber intraocular lens, pseudophakic

Similar devices in this category

Other devices filed under IOLs, APHAKIC, MONOFOCAL, ASPHERIC, 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
Other properties (17, all answered No)