Alcon Laboratories, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000016248
- Devices
- 18,138
- Registrations
- EUDAMED
- FDA recalls
- 16
At a glance
EU certificates
4 of 8 in force.
Market reach
- European Union
- EUDAMED actor, 8 certificates
- United States
- FDA recalls
- Authorised rep.
- Alcon Laboratories BelgiumBE
What Alcon Laboratories, Inc. makes
Alcon Laboratories, Inc. manufactures intraocular lenses for cataract surgery, including posterior-chamber and anterior-chamber pseudophakic lenses such as ACRYSOF® Monoflex®, Clareon™, and AcrySof™ IQ PanOptix™ Toric UV IOL. The company also produces single-use ophthalmic surgical kits, cannulation sets, irrigation/infusion/aspiration cannulas, surgical drapes, and non-bioabsorbable nylon sutures for eye procedures. Examples include the Small Parts Kit (Bulk Non-Sterile), ACRYSOF® IQ RESTOR® Monoflex®, and AcrySof™ IQ Vivity™.
The portfolio includes devices classified as Class I, Class II, Class IIa, and Class III under regulatory frameworks, with listings in the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) registry. The company is based in the United States.
Catalogue
Search and filter all 18,138 devicesShowing 1-50 of 18,138
Company details
- EUDAMED SRN
- US-MF-000016248
- SRN (system / procedure pack)
- US-PR-000037951
- DUNS number
- 008018525
- EUDAMED status
- Active
- EUDAMED registered name
- Alcon Laboratories, Inc.
- EUDAMED abbreviated name
- ALI
- Registered address
- 6201, South Freeway, 76134-2099, Fort Worth, United States
- Website
- Alcon.com
- Phone
- +1(800)862-5266
- PRRC contact
- Stephanie Baker
EUDAMED certificates
8 certificates4 valid, 0 expired, 4 withdrawn or suspendedMDR 8next expiry 23 Jun 2027
TÜV SÜD Product Service GmbH 0123 7 certificates
- G12 020895 0421 Active
Quality management system EU MDR
- Issued
- 12 Jun 2026
- Expires
- 11 Jun 2031
- G70 020895 0397 Active
Technical documentation EU MDR
- Issued
- 11 Jun 2026
- Expires
- 29 Aug 2028
- Reason
- Add device or group
- G10 020895 0396 Expiring
Quality management system EU MDR
- Issued
- 23 Jun 2026
- Expires
- 23 Jun 2027
- Reason
- Other
- G70 020895 0419 Withdrawn
Technical documentation EU MDR
- Issued
- 11 Jun 2026
- Expires
- 26 Jun 2030
- Reason
- Transferred to other nb
- G70 020895 0414 Withdrawn
Technical documentation EU MDR
- Issued
- 11 Jun 2026
- Expires
- 20 Jan 2030
- Reason
- Transferred to other nb
- G12 020895 0403 Withdrawn
Quality management system EU MDR
- Issued
- 4 Jul 2025
- Expires
- 5 Dec 2029
- Reason
- Transferred to other nb
- G70 020895 0412 Withdrawn
Technical documentation EU MDR
- Issued
- 11 Jun 2026
- Expires
- 4 Dec 2029
- Reason
- Transferred to other nb
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 810567 Active
Quality management system EU MDR
- Issued
- 24 Jul 2026
- Expires
- 8 Jun 2030
- Valid from
- 3 Aug 2026
- Reason
- Add device or group
FDA recalls
FDA recall records list 16 recalls initiated by Alcon Laboratories, Inc., the earliest on 2002-11-18 and the most recent on 2009-04-29. By recorded status: 16 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2009
- 29 Apr 2009 Z-1643-2009 Unclassified (pre-2012) Terminated Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that oxidation can occur on some of the blades.
- 29 Apr 2009 Z-1644-2009 Unclassified (pre-2012) Terminated Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that oxidation can occur on some of the blades.
2008
- 26 Sep 2008 Z-0274-2009 Unclassified (pre-2012) Terminated Alcon had identified that indications for use unapproved by the Food and Drug Administration are included in the PurePoint Laser System Operator's Manual, Catalog Number 8065751131, Revision B.
Full distribution text
- 7 Jul 2008 Z-2441-2008 Unclassified (pre-2012) Terminated Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion and damage to the lens.
- 26 Sep 2008 Z-0274-2009 Unclassified (pre-2012) Terminated Alcon had identified that indications for use unapproved by the Food and Drug Administration are included in the PurePoint Laser System Operator's Manual, Catalog Number 8065751131, Revision B.
2006
- 22 Dec 2006 Z-0560-2007 Unclassified (pre-2012) Terminated Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.
- 22 Dec 2006 Z-0561-2007 Unclassified (pre-2012) Terminated Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.
- 22 Dec 2006 Z-0562-2007 Unclassified (pre-2012) Terminated Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.
- 22 Dec 2006 Z-0563-2007 Unclassified (pre-2012) Terminated Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.
- 22 Dec 2006 Z-0564-2007 Unclassified (pre-2012) Terminated Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.
- 14 Dec 2006 Z-0429-2007 Unclassified (pre-2012) Terminated Intraocular lenses exposed to extreme temperatures while in storage.
Show all 16 recalls
2006
- 14 Dec 2006 Z-0430-2007 Unclassified (pre-2012) Terminated Intraocular lenses exposed to extreme temperatures while in storage.
- 14 Dec 2006 Z-0431-2007 Unclassified (pre-2012) Terminated Intraocular lenses exposed to extreme temperatures while in storage.
2005
- 1 Aug 2005 Z-1147-06 Unclassified (pre-2012) Terminated Alcon has identified a software error associated with the use of the Measuring Mode (ruler tool) on the LADARVision4000 Excimer Laser Systems. Use of this feature after alignment of the horizontal reference line will negate compensation for cyclotorsion on CustomCornea procedures, possibly adversely affecting clinical outcomes.
2003
- 18 Nov 2003 Z-0229-04 Unclassified (pre-2012) Terminated The firm initiated the recall on 11/18/2003 via letters to all consignees. The letter advises physicians to stop using any patient bracelets (blue color) that contain the word 'stickoxid', destroy all blue bracelets, and identify all patients who had either ISPAN gas administered who may still have a bubble present in the eye.
- 21 Jul 2003 Z-1078-03 Unclassified (pre-2012) Terminated Software error could, under specific circumstances, allow the patient's centration images and data to be stored incorrectly.
2002
- 18 Nov 2002 Z-0612-03 Unclassified (pre-2012) Terminated Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated.
Full distribution text
- 18 Nov 2002 Z-0612-03 Unclassified (pre-2012) Terminated Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated.
Frequently asked questions
How many devices does Alcon Laboratories, Inc. have in the registry?
The registry currently lists 18138 devices for Alcon Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alcon Laboratories, Inc.'s devices?
Among its 50 most recently registered devices, Alcon Laboratories, Inc. has devices listed in EUDAMED (50 devices).
What risk classes do Alcon Laboratories, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Alcon Laboratories, Inc.'s devices are Class IIa and Class IIb. Each device page shows its own class and authorisation.
Are there FDA recall records for Alcon Laboratories, Inc.?
FDA recall records list 16 recalls initiated by Alcon Laboratories, Inc., the most recent initiated on 29 Apr 2009. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for Alcon Laboratories, Inc.?
EUDAMED lists 8 certificates for Alcon Laboratories, Inc. (quality management system; technical documentation) under MDR. 1 is recorded with the status issued. The most recent was issued on 24 Jul 2026.
What are the newest devices from Alcon Laboratories, Inc. in the registry?
The most recently registered devices listed for Alcon Laboratories, Inc. include AcrySof, Systane, Cannulas and Cystitomes - Cystitomes and AIR OPTIX Night & Day AQUA.