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Acrysof® SN60AT

by Alcon Laboratories, Inc. 59 variants

Ref SN60AT.195

Acrysof® SN60AT (SN60AT.195) 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 1 Nov 2026 (Basic UDI-DI B-00380650130297) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00380650130297), 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-00380650130297 Basic UDI-DI 00380650130297UDI-DIDate1 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380650130297 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00380650130297 registered 1 Nov 2026 Active
  • FDA GUDID UDI-DI 00380650130297 listed 24 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380650130297
  2. Registered EUDAMED B-00380650130297

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  • Withdrawn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® GUDID
Generic name
Posterior-chamber intraocular lens, pseudophakic
Device name
AcrySof Single-Piece - Natural Single-Piece IOL
Model / Ref / Catalog
SN60AT.195, SN60AT
Primary DI / UDI-DI
00380650130297
Basic UDI-DI
B-00380650130297
FDA product code
HQL
EMDN code
P030102090101 IOLs, APHAKIC, MONOFOCAL, SPHERICAL, 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
SN60AT.195
GUDID
SN60AT
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, SPHERICAL.

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)