Alcon Research LLC

FDA Regulatory Profile

Summary

Total Recalls
108 (8 Class I)
510(k) Clearances
17
Inspections
41
Compliance Actions
0

Known Names

alcon research, alcon research, ltd. dba alcon laboratories

Recent Recalls

NumberClassProductDate
Z-0939-2026Class IBrand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 1718November 24, 2025
Z-0326-2026Class IIAlcon PRECISION1 One-Day Contact Lenses, -2.25D.September 30, 2025
Z-0581-2026Class IICONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20September 15, 2025
Z-0307-2026Class IIBrand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation suAugust 5, 2025
Z-0308-2026Class IIBrand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation suAugust 5, 2025
Z-0306-2026Class IIBrand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation suAugust 5, 2025
Z-0304-2026Class IIBrand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation suAugust 5, 2025
Z-0305-2026Class IIBrand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation suAugust 5, 2025
Z-2108-2025Class IIBrand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy ProcedureApril 28, 2025
Z-2110-2025Class IIBrand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'AtApril 28, 2025
Z-2109-2025Class IIBrand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure PApril 28, 2025
Z-1293-2025Class IIAlcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-February 10, 2025
D-0200-2025Class ISystane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon LaborDecember 18, 2024
Z-0835-2025Class IIBrand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763November 13, 2024
Z-0490-2025Class IIIa) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING,October 15, 2024
Z-3313-2024Class IIDAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,August 8, 2024
Z-2655-2024Class IIProduct Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 806591190July 15, 2024
Z-2679-2024Class IIProduct Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A July 15, 2024
Z-2654-2024Class IIProduct Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog Number: 8065772745 SofJuly 15, 2024
Z-2667-2024Class IIProduct Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Catalog Number: 806599274July 15, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K191650LEGION SystemNovember 1, 2019
K161794CENTURION Vision System (Active SentryTM)April 14, 2017
K170520HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+March 22, 2017
K141065CONSTELLATION VISION SYSTEMAugust 22, 2014
K121031WAVELIGHT FS200 PATIENT INTERFACE 1505June 21, 2012
K112977MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)March 27, 2012
K11095127+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27October 17, 2011
K110166CLEARCUT S SAFETY KNIFEMay 20, 2011
K102860ALCON MULTI-PIRPOSE DISINFECTING SOLUTIONMay 10, 2011
K101006WAVELIGHT FS200 LASER SYSTEM MODEL: FS200October 21, 2010
K093305ENHANCED ULTRA VIT PROBEApril 2, 2010
K091777ALCON ULTRACHOPPEROctober 20, 2009
K082845INFINITI VISION SYSTEM WITH OZIL IPFebruary 12, 2009
K062930LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEMNovember 8, 2006
K050729ALCON MULTI-PURPOSE DISINFECTING SOLUTIONSeptember 14, 2005
K003768MONARCH II IOL DELIVERY SYSTEMJanuary 5, 2001
K001157MONARCH II IOL DELIVERY SYSTEMJune 27, 2000