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Sign in to claim this brandAlcon Laboratories, Inc.
United States·US-MF-000016248
Last updated May 24, 2026
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.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Alcon Laboratories, Inc. primarily manufacture?
Alcon Laboratories, Inc. specializes in ophthalmic devices, particularly intraocular lenses (IOLs) used in cataract surgery. Their portfolio includes posterior-chamber and anterior-chamber pseudophakic IOLs, such as the ACRYSOF® Monoflex®, Clareon™, and AcrySof™ IQ PanOptix™ Toric UV IOL. Additionally, they produce single-use surgical kits, cannulation sets, irrigation/infusion/aspiration cannulas, surgical drapes, and non-bioabsorbable nylon sutures for eye procedures. These devices are designed to support various stages of ophthalmic surgeries.
Where is Alcon Laboratories, Inc. based, and how does this affect its regulatory compliance?
Alcon Laboratories, Inc. is based in the United States. As a US-based manufacturer, its devices must comply with both FDA regulations in the US and EU MDR requirements if marketed in the European Economic Area. The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) registry and the EU’s eudamed database, ensuring traceability and regulatory transparency for authorized products.
Which regulatory registries list Alcon Laboratories, Inc.’s devices, and why is this important?
Alcon Laboratories, Inc.’s devices are listed in the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) registry. These registries are critical for tracking authorized medical devices, ensuring compliance with regulatory requirements, and providing transparency to healthcare providers, regulators, and patients. Listing in these databases helps verify the legitimacy and regulatory status of specific devices, such as intraocular lenses or surgical kits.
How are Alcon Laboratories, Inc.’s devices classified under regulatory frameworks?
Alcon Laboratories, Inc.’s devices span multiple regulatory classes, including Class I, Class II, Class IIa, and Class III. The classification depends on factors like the device’s risk level, intended use, and potential impact on patient safety. For example, intraocular lenses like the Clareon™ or AcrySof™ IQ Vivity™ are typically Class III due to their direct implantation into the body, while single-use surgical kits or cannulas may fall into lower-risk classes like Class I or II. Classification determines the regulatory scrutiny and authorization process required for each device.
Why do some of Alcon’s intraocular lenses appear in multiple registries like eudamed and the FDA’s UDI system?
Intraocular lenses from Alcon, such as the ACRYSOF® IQ RESTOR® Monoflex® or Clareon Vivity, may appear in both eudamed and the FDA’s UDI registry because these devices are marketed globally. The EU’s eudamed database is used for devices sold within the European Economic Area, while the FDA’s UDI system tracks devices authorized in the US. Listing in both ensures compliance with regional regulations and provides clear identification for healthcare professionals and authorities in different markets.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 6201, South Freeway, Fort Worth, United States
- Website
- Alcon.com
- —
- —
- [email protected]
- Phone
- +1(800)862-5266
- PRRC Contact
- —
- EUDAMED SRN
- US-MF-000016248
- FDA FEI Number
- —
- DUNS Number
- 008018525
Catalogue (9090)
Page 2 of 182| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Clareon PanOptix Pro | PXCAT6 | FDA UDI | Class III | Active |
| AcrySof™ IQ PanOptix™ Toric UV IOL | TFAT60 | FDA UDI | Class III | Active |
| Clareon PanOptix Pro | PXCAT6 | FDA UDI | Class III | Active |
| Clareon | CNW0T5 | FDA UDI | Class III | Active |
| AcrySof™ IQ Vivity™ | DFT015 | FDA UDI | Class III | Active |
| Clareon Vivity Extended Vision Hydrophobic IOL with the AutonoMe | CNAET0 | FDA UDI | Class III | Active |
| Acrysof® | SN6AT4 | FDA UDI | Class III | Active |
| AcrySof® IQ PanOptix® Toric Trifocal IOL | TFNT60 | FDA UDI | Class III | Active |
| Clareon PanOptix Pro | PXYWT6 | FDA UDI | Class III | Active |
| Constellation, Ultravit, 25+, TotalPlus, EdgePlus | 8065751767 | FDA UDI | Class II | Active |
| Clareon | SY60WF | FDA UDI | Class III | Active |
| Alcon Eye-Pak | 8065117320 | FDA UDI | Class II | Active |
| AcrySof™ IQ PanOptix™ UV IOL | TFAT00 | FDA UDI | Class III | Active |
| AcrySof® ACRYSERT® | SN60WS | FDA UDI | Class III | Unknown |
| Clareon | CNWET4 | FDA UDI | Class III | Active |
| Alcon | 00380650004673 | FDA UDI | Class I | Active |
| Unity | 00380650003782 | FDA UDI | Class II | Active |
| Clareon | CNW0T7 | FDA UDI | Class III | Active |
| Clareon | CCW0T6 | FDA UDI | Class III | Active |
| Clareon | CNW0T9 | FDA UDI | Class III | Active |
| Clareon Vivity | CNWET0 | FDA UDI | Class III | Active |
| AcrySof™ IQ Vivity™ | DFT615 | FDA UDI | Class III | Active |
| Clareon | SY60WF | FDA UDI | Class III | Active |
| Clareon PanOptix Pro | PXCAT5 | FDA UDI | Class III | Active |
| Acrysof® Iq Restor® | SN6AD1 | FDA UDI | Class III | Unknown |
| Acrysof® | SN6AT6 | FDA UDI | Class III | Active |
| Clareon PanOptix Pro | PXCWT3 | FDA UDI | Class III | Active |
| ACRYSOF® Monoflex® | MA30AC | FDA UDI | Class III | Unknown |
| Clareon Vivity Toric Extended Vision UV Absorbing IOLs with the AutonoMe | CCAET4 | FDA UDI | Class III | Active |
| AcrySof™ IQ PanOptix™ Toric UV IOL | TFAT50 | FDA UDI | Class III | Active |
| ACRYSOF® Monoflex® | MA30AC | FDA UDI | Class III | Unknown |
| ACRYSOF® IQ RESTOR ® Monoflex® | MN6AD1 | FDA UDI | Class III | Active |
| AcrySof Toric Aspheric UV Absorbing IOL | SA6AT5 | FDA UDI | Class III | Active |
| AcrySof® IQ ReSTOR® | SV25T6 | FDA UDI | Class III | Unknown |
| Clareon PanOptix Pro | PXCAT6 | FDA UDI | Class III | Active |
| Clareon PanOptix Pro | PXCAT4 | FDA UDI | Class III | Active |
| Acrysof® Iq Restor® | SN6AD1 | FDA UDI | Class III | Unknown |
| Clareon PanOptix Pro | PXCAT4 | FDA UDI | Class III | Active |
| AcrySof™ IQ PanOptix™ Toric UV IOL | TFAT60 | FDA UDI | Class III | Active |
| AcrySof® IQ ReSTOR® | SV25T5 | FDA UDI | Class III | Unknown |
| Clareon PanOptix Pro | PXCAT0 | FDA UDI | Class III | Active |
| Acrysof® | SN6AT7 | FDA UDI | Class III | Active |
| Alcon | 8065751585 | FDA UDI | Class II | Active |
| AcrySof™ IQ Vivity™ | DFT415 | FDA UDI | Class III | Active |
| AcrySof® IQ PanOptix® Toric Trifocal IOL | TFNT50 | FDA UDI | Class III | Active |
| Acrysof, Iq Restor | SND1T4 | FDA UDI | Class III | Unknown |
| Acrysof, Iq Restor | SND1T4 | FDA UDI | Class III | Unknown |
| ACRYSOF® Monoflex® | MN60AC | FDA UDI | Class III | Active |
| Clareon™ | CNWTT5 | FDA UDI | Class III | Active |
| AcrySof® IQ PanOptix® Trifocal IOL | TFNT00 | FDA UDI | Class III | Active |
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FDA Recalls (17)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Alcon Laboratories, Inc. has 16 recall records initiated between November 18, 2002, and April 29, 2009, all of which are marked as terminated. The reasons cited include non-conformance to specifications—such as oxidation in trocar blades, software errors affecting data storage and alignment in medical devices, exposure of intraocular lenses to extreme temperatures, glue degradation causing misalignment, mislabeled delivery cartridges, unapproved usage instructions in operator manuals, software malfunctions in laser systems, and incomplete sterile packaging seals on surgical blades.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 17, 2015 | Z-2322-2015 | — | terminated | Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment. |
| Apr 29, 2009 | Z-1644-2009 | — | 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. |
| Apr 29, 2009 | Z-1643-2009 | — | 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. |
| Sep 26, 2008 | Z-0274-2009 | — | 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. |
| Jul 7, 2008 | Z-2441-2008 | — | terminated | Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion and damage to the lens. |
| Dec 22, 2006 | Z-0561-2007 | — | terminated | Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs. |
| Dec 22, 2006 | Z-0560-2007 | — | terminated | Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs. |
| Dec 22, 2006 | Z-0562-2007 | — | terminated | Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs. |
| Dec 22, 2006 | Z-0564-2007 | — | terminated | Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs. |
| Dec 22, 2006 | Z-0563-2007 | — | terminated | Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs. |
| Dec 14, 2006 | Z-0429-2007 | — | terminated | Intraocular lenses exposed to extreme temperatures while in storage. |
| Dec 14, 2006 | Z-0431-2007 | — | terminated | Intraocular lenses exposed to extreme temperatures while in storage. |
| Dec 14, 2006 | Z-0430-2007 | — | terminated | Intraocular lenses exposed to extreme temperatures while in storage. |
| Aug 1, 2005 | Z-1147-06 | — | 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. |
| Nov 18, 2003 | Z-0229-04 | — | 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. |
| Jul 21, 2003 | Z-1078-03 | — | terminated | Software error could, under specific circumstances, allow the patient's centration images and data to be stored incorrectly. |
| Nov 18, 2002 | Z-0612-03 | — | terminated | Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated. |