Stock: ALC. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
129
De Novo: 0
PMA approvals
39
1,346 supplements
Recalled products
143
7 class I
Adverse event reports
132K
15 deaths reported
Alcon has 143 recalled medical device products in 70 recall actions in the records, 7 of them class I (the most serious kind). The newest recall started on Nov 24, 2025. In 2024 it had 46 recalled products.
129 510(k) clearances, 0 De Novo grants and 39 original PMA approvals for high-risk devices, plus 1,346 PMA supplements (changes to approved devices). The newest decision was on Aug 17, 2026.
132,087 reports in total: 15 deaths, 41,256 injuries and 86,871 malfunctions were reported. 15,328 reports were received in 2025. A report alone does not show that the device caused the problem.
Last 15 years
| Year | 510(k) clearance | De Novo grant | PMA approval | PMA supplement |
|---|---|---|---|---|
| 2026 | 1 | 0 | 0 | 34 |
| 2025 | 3 | 0 | 0 | 37 |
| 2024 | 3 | 0 | 2 | 43 |
| 2023 |
By product code, all years
All device makers and procedures · ALC stock page
Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to ALC with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.
| 3 |
| 0 |
| 1 |
| 42 |
| 2022 | 1 | 0 | 0 | 23 |
| 2021 | 3 | 0 | 0 | 40 |
| 2020 | 2 | 0 | 1 | 34 |
| 2019 | 5 | 0 | 0 | 38 |
| 2018 | 6 | 0 | 1 | 48 |
| 2017 | 6 | 0 | 0 | 50 |
| 2016 | 7 | 0 | 1 | 48 |
| 2015 | 1 | 0 | 0 | 36 |
| 2014 | 2 | 0 | 0 | 23 |
| 2013 | 0 | 0 | 0 | 40 |
| 2012 | 6 | 0 | 0 | 45 |
| 2011 | 3 | 0 | 0 | 9 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 0 | 0 | 10,623 | 3 |
| 2025 | 12 | 1 | 15,328 | - |
| 2024 | 46 | 0 | 11,700 | - |
| 2023 | 9 | 0 | 7,757 | - |
| 2022 | 3 | 0 | 6,815 | 1 |
| 2021 | 1 | 0 | 5,733 | - |
| 2020 | 2 | 0 | 4,618 | - |
| 2019 | 0 | 0 | 5,750 | - |
| 2018 | 8 | 4 | 5,559 | - |
| 2017 | 5 | 0 | 5,330 | - |
| 2016 | 7 | 0 | 5,508 | 1 |
| 2015 | 9 | 2 | 5,616 | 2 |
| 2014 | 6 | 0 | 4,383 | - |
| 2013 | 1 | 0 | 4,375 | 1 |
| 2012 | 1 | 0 | 4,562 | 1 |