Data / Medical devices / Ireland / Alcon Laboratories Ireland Ltd.
Alcon Laboratories Ireland Ltd.: FDA-registered device maker in CORK Cork(City), Ireland, 3 PMA approvals
Alcon Laboratories Ireland Ltd. is registered with the FDA (registration 9612169) in CORK Cork(City), Ireland. It lists 4 device types. The FDA files 3 PMA approvals under its listings, the newest dated January 7, 2020. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9612169
- FEI number
- 3002808262
- Address
- Cork Business And Technology Park Model Farm RD., CORK Cork(City), Ireland, -
- Owner or operator
- Alcon Laboratories, Inc. (1610287)
- Roles
- Manufacturer
- First device listed
- February 28, 2006
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Extended Depth Of Focus Intraocular Lens | POE | 3 | Manufacturer | accessdata.fda.gov |
| Intraocular Lens | HQL | 3 | Manufacturer | accessdata.fda.gov |
| Lens, Intraocular, Toric Optics | MJP | 3 | Manufacturer | accessdata.fda.gov |
| Lens, Multifocal Intraocular | MFK | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| January 7, 2020 | P190018 | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens | HQL | 49 | August 17, 2026 | accessdata.fda.gov |
| March 21, 2005 | P040020 | ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL | MFK | 118 | July 6, 2026 | accessdata.fda.gov |
| December 22, 1994 | P930014 | ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES | HQL | 161 | July 8, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 11, 2022 | 90194 | Class II | Terminated | Alcon Clareon IOL with AutonoMe Delivery System | Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance. | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Multifocal Intraocular
- All makers of Lens, Intraocular, Toric Optics
- All makers of Intraocular Lens
- All makers of Extended Depth Of Focus Intraocular Lens
Updated August 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.