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Alcon Research LLC FDA Recalls
67 recalls on file across drugs, devices, 2 of them Class I and 66 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort WClass IIApr 21, 2026Lack of Assurance of Sterility: Due to FDA inspection observ |
| GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, TexasClass IIApr 21, 2026Lack of Assurance of Sterility: Due to FDA inspection observ |
| Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 1920Class INov 24, 2025Ophthalmic procedure packs may have incomplete seals affecti |
| Alcon PRECISION1 One-Day Contact Lenses, -2.25D.Class IISep 30, 2025Potential for a weak seal in some units resulting in comprom |
| CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 806Class IISep 15, 2025XXX |
| Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles ModClass IIAug 5, 2025Due to incomplete seals in the pouch which provide the steri |
| Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles ModClass IIAug 5, 2025Due to incomplete seals in the pouch which provide the steri |
| Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles ModClass IIAug 5, 2025Due to incomplete seals in the pouch which provide the steri |
| Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles ModClass IIAug 5, 2025Due to incomplete seals in the pouch which provide the steri |
| Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles ModClass IIAug 5, 2025Due to incomplete seals in the pouch which provide the steri |
| Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - AffecteClass IIApr 28, 2025Due to the potential that some units within specific lots we |
| Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog NuClass IIApr 28, 2025Due to the potential that some units within specific lots we |
| Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Class IIApr 28, 2025Due to the potential that some units within specific lots we |
| Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-Class IIFeb 10, 2025Customer-designed sterile surgical procedure packs contain l |
| Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Class IDec 18, 2024Non-Sterility |
| Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product DescriptiClass IINov 13, 2024Increase in complaints associated with a molding defect with |
| a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; Class IIIOct 15, 2024Reported breakage in the tubing Anti-Reflux Valve (ARV) due |
| DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,Class IIAug 8, 2024Material with a quality issue was used in contact lens produ |
| Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/AClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software Version: N/A Component: N/AClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog Number: 8065772745 Software Version: N/A Class IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog Number: 8065983265 Software Version: N/A PClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Catalog Number: 8065992647 Software Version:Class IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992245 Software Version: N/A ProduClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 SoftwarClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product DesClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom PakClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A ComponenClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/AClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Catalog Number: 8065993047 Software Version:Class IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A Component: N/AClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number: 8065983065 Software Version: N/A PClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Number: 8065772445 Software Version: N/A PrClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Model/Catalog Number: 8065772465 Software Version: N/A PrClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version:Class IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992561 Software Version: N/A ProduClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog Number: 8065990002 Software Version:Class IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version:Class IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/AClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2 Model/Catalog Number: 8065772265 Software Version: N/A PrClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product DescriptionClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software Version: N/A Component: N/AClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/AClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Catalog Number: 8065993045 Software Version:Class IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software Version: N/A Component: N/AClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software Version: N/A Component: N/AClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2 Model/Catalog Number: 8065772245 Software Version: N/A PrClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 8065830077 Software Version: N/A Product DescriptiClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Model/Catalog Number: 8065992745 Software Version:Class IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992445 Software Version: N/A ProduClass IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Class IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095 Software Version: N/A Component:Class IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Catalog Number: 8065992747 Software Version:Class IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065982465 Software Class IIJul 15, 2024Alcon has detected an increase in complaint reports related |
| Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399Class IIMay 23, 2024After surgery initiation, while using surgical image guidanc |
| 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Class IIApr 22, 2024Alcon has detected an increase in complaint reports related |
| ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product DescClass IIApr 22, 2024Alcon has detected an increase in complaint reports related |
| ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product DescClass IIApr 22, 2024Alcon has detected an increase in complaint reports related |
| ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product DescriClass IIApr 22, 2024Alcon has detected an increase in complaint reports related |
| Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom PaClass IIMar 15, 2024Due to complaints of particulates, residue, occlusions, and |
| SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 1801Class IIFeb 21, 2024Medline Bulb irrigation syringes recalled due to potential f |
| Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTRClass IISep 7, 2023Custom surgical procedure packs contain latex gloves but are |
| Constellation Vision System, REF: 8065751150Class IIAug 18, 2023Ophthalmic microsurgical vision systems have a new Printed C |
| Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SClass IIMar 10, 2023Sterility; Steril surgical procedure packs contain incomplet |
| Alcon Custom Pak Surgical Procedure PackClass IIOct 31, 2022Due to difficulty removing the liner on the adhesive compone |
| Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFFClass IIJun 9, 2022Due to latex gloves being include in Custom Pak. Kits are s |
| Alcon Custom Ophthalmic Surgical Procedure PacksClass IIFeb 2, 2021Reports have been received concerning mold found on gowns i |