Alcon Research, Llc
6201 SOUTH FREEWAY, Fort Worth, TX, US
Registered product codes
27 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 1610287.
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
8 on file
Top refusal reasons
Compare to industry ↗- Division of Southeast Imports (DSEI)Sep 19, 2024
86HQC \ UNIT, PHACOFRAGMENTATION
- Division of Northern Border Imports (DNBI)May 13, 2024
86LPN \ ACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS
- Division of Northern Border Imports (DNBI)May 13, 2024
86LPN \ ACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS
- Division of Northern Border Imports (DNBI)May 13, 2024
86LPN \ ACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS
- Division of Northern Border Imports (DNBI)May 13, 2024
86LPN \ ACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS
- Division of Northern Border Imports (DNBI)May 13, 2024
86LPN \ ACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS
- Division of Northern Border Imports (DNBI)May 13, 2024
86LPN \ ACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS
- Division of Southeast Imports (DSEI)Feb 27, 2024
86LPL \ LENSES, SOFT CONTACT, DAILY WEAR