Alcon Research, Llc
15800 Alton Pkwy, IRVINE, CA, US
Registered product codes
20 product codes
Recent MDR events
56,351 on file
- Clareon Aspheric Hydrophobic Acrylic IOLJul 31, 2026Malfunction1119421-2026-01590
- Clareon Vivity Toric Extended Vision Hydrophobic IOLJul 31, 2026Malfunction1119421-2026-01591
- UNITY Vision System, Accessory, Active Sentry HandpieceJul 31, 2026Injury2028159-2026-01174
- UNITY Vision System, Accessory, Active Sentry HandpieceJul 31, 2026Injury2028159-2026-01173
- UNITY Vision System, Accessory, Active Sentry HandpieceJul 31, 2026Injury2028159-2026-01175
- CONSTELLATION Surgical Procedure PackJul 31, 2026Malfunction1644019-2026-04095
- HyperVit Vitrectomy ProbeJul 31, 2026Malfunction1644019-2026-04097
- CONSTELLATION Surgical Procedure PackJul 31, 2026Malfunction1644019-2026-04096
- CONSTELLATION Surgical Procedure PackJul 31, 2026Malfunction1644019-2026-04098
- ClearCut KnivesJul 31, 2026Malfunction2523835-2026-00796
Recalls
67 on file
- Open, ClassifiedDec 23, 2025
Ophthalmic procedure packs may have incomplete seals affecting sterility.
View FDA record ↗ - Open, ClassifiedNov 21, 2025
XXX
View FDA record ↗ - Open, ClassifiedOct 24, 2025
Due to incomplete seals in the pouch which provide the sterile barrier.
View FDA record ↗ - Open, ClassifiedOct 24, 2025
Due to incomplete seals in the pouch which provide the sterile barrier.
View FDA record ↗ - Open, ClassifiedOct 24, 2025
Due to incomplete seals in the pouch which provide the sterile barrier.
View FDA record ↗ - Open, ClassifiedOct 24, 2025
Due to incomplete seals in the pouch which provide the sterile barrier.
View FDA record ↗ - Open, ClassifiedOct 24, 2025
Due to incomplete seals in the pouch which provide the sterile barrier.
View FDA record ↗ - Open, ClassifiedOct 24, 2025
Potential for a weak seal in some units resulting in compromise in sterility.
View FDA record ↗ - Open, ClassifiedJul 10, 2025
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.
View FDA record ↗ - Open, ClassifiedJul 10, 2025
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.
View FDA record ↗
Compliance history
Matched by FEI 1000125771.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.