Alcon Research LLC
Alcon Research LLC appears in FDA public data with 110 recalls — including 8 Class I (most serious) —, 17 510(k) clearances, 41 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0492-2026, Class II) was initiated on April 21, 2026. Its most recent 510(k) clearance was granted on November 1, 2019.
Summary
- Total Recalls
- 110 (8 Class I)
- 510(k) Clearances
- 17
- Inspections
- 41
- Compliance Actions
- 0
Known Names
alcon research, alcon research, ltd. dba alcon laboratories
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0492-2026 | Class II | GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc | April 21, 2026 |
| D-0491-2026 | Class II | Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Labora | April 21, 2026 |
| Z-0939-2026 | Class I | Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 1718 | November 24, 2025 |
| Z-0326-2026 | Class II | Alcon PRECISION1 One-Day Contact Lenses, -2.25D. | September 30, 2025 |
| Z-0581-2026 | Class II | CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20 | September 15, 2025 |
| Z-0307-2026 | Class II | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation su | August 5, 2025 |
| Z-0305-2026 | Class II | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation su | August 5, 2025 |
| Z-0306-2026 | Class II | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation su | August 5, 2025 |
| Z-0308-2026 | Class II | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation su | August 5, 2025 |
| Z-0304-2026 | Class II | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation su | August 5, 2025 |
| Z-2110-2025 | Class II | Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'At | April 28, 2025 |
| Z-2108-2025 | Class II | Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure | April 28, 2025 |
| Z-2109-2025 | Class II | Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure P | April 28, 2025 |
| Z-1293-2025 | Class II | Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141- | February 10, 2025 |
| D-0200-2025 | Class I | Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Labor | December 18, 2024 |
| Z-0835-2025 | Class II | Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 | November 13, 2024 |
| Z-0490-2025 | Class III | a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, | October 15, 2024 |
| Z-3313-2024 | Class II | DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere, | August 8, 2024 |
| Z-2679-2024 | Class II | Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A | July 15, 2024 |
| Z-2654-2024 | Class II | Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog Number: 8065772745 Sof | July 15, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K191650 | LEGION System | November 1, 2019 |
| K161794 | CENTURION Vision System (Active SentryTM) | April 14, 2017 |
| K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ | March 22, 2017 |
| K141065 | CONSTELLATION VISION SYSTEM | August 22, 2014 |
| K121031 | WAVELIGHT FS200 PATIENT INTERFACE 1505 | June 21, 2012 |
| K112977 | MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) | March 27, 2012 |
| K110951 | 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27 | October 17, 2011 |
| K110166 | CLEARCUT S SAFETY KNIFE | May 20, 2011 |
| K102860 | ALCON MULTI-PIRPOSE DISINFECTING SOLUTION | May 10, 2011 |
| K101006 | WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 | October 21, 2010 |
| K093305 | ENHANCED ULTRA VIT PROBE | April 2, 2010 |
| K091777 | ALCON ULTRACHOPPER | October 20, 2009 |
| K082845 | INFINITI VISION SYSTEM WITH OZIL IP | February 12, 2009 |
| K062930 | LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM | November 8, 2006 |
| K050729 | ALCON MULTI-PURPOSE DISINFECTING SOLUTION | September 14, 2005 |
| K003768 | MONARCH II IOL DELIVERY SYSTEM | January 5, 2001 |
| K001157 | MONARCH II IOL DELIVERY SYSTEM | June 27, 2000 |