--- title: "Alcon Research, LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Alcon Research, LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/alcon-research-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Alcon Research, LLC recall records **66** reported ongoing 66 records in this archive. Latest source date Apr 21, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Apr 21, 2026 FDA drug enforcement ### [Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01](https://isitonrecall.com/recall/fda-drug-d-0491-2026-systane-lubricant-eye-gel-night-gel-sterile-10g-0-35-oz-processed-in-france-for-alcon-laboratiroes-i/) Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. Class II Reported ongoing Distribution: Nationwide within the United States [Official source for Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Lab...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0491-2026%22) Apr 21, 2026 FDA drug enforcement ### [GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.](https://isitonrecall.com/recall/fda-drug-d-0492-2026-genteal-tears-lubricant-eye-gel-sterile-10g-0-34-fl-oz-distributed-by-alcon-laboratories-inc-fort-wo/) Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. Class II Reported ongoing Distribution: Nationwide within the United States [Official source for GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0492-2026%22) Nov 24, 2025 FDA device enforcement ### [Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Desc...](https://isitonrecall.com/recall/fda-device-z-0939-2026-brand-name-alcon-laboratories-inc-product-name-custom-pak-model-catalog-numbers-9903-20-17188-04-197/) Ophthalmic procedure packs may have incomplete seals affecting sterility. Class I Reported ongoing Distribution: US Nationwide distribution in the states of CA, ND, UT. [Official source for Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 171...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0939-2026%22) Sep 30, 2025 FDA device enforcement ### [Alcon PRECISION1 One-Day Contact Lenses, -2.25D.](https://isitonrecall.com/recall/fda-device-z-0326-2026-alcon-precision1-one-day-contact-lenses-2-25d/) Potential for a weak seal in some units resulting in compromise in sterility. Class II Reported ongoing Distribution: Worldwide - US distribution in the states of Alabama, Arizona, Arkansas, Connecticut, Florida, Idaho, Iowa, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, ... [Official source for Alcon PRECISION1 One-Day Contact Lenses, -2.25D.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0326-2026%22) Sep 15, 2025 FDA device enforcement ### [CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095...](https://isitonrecall.com/recall/fda-device-z-0581-2026-constellation-ultravit-10k-and-constellation-hypervit-20k-description-ref-25-totalplus-cp-pak-20k-cp/) XXX Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of PA, MN, CA, FL, LA, CO, KS, IL, AK, OH, NY, NM, DE, TX, GA, NJ, MI, SC, AR, IN, OR, VA, WI, AZ, TN, KY, AL, MA,... [Official source for CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0581-2026%22) Aug 5, 2025 FDA device enforcement ### [Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Prod...](https://isitonrecall.com/recall/fda-device-z-0304-2026-brand-name-alcon-laboratories-inc-product-name-accessory-devices-for-unity-and-constellation-surgica/) Due to incomplete seals in the pouch which provide the sterile barrier. Class II Reported ongoing Distribution: Worldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, ... [Official source for Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0304-2026%22) Aug 5, 2025 FDA device enforcement ### [Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Prod...](https://isitonrecall.com/recall/fda-device-z-0305-2026-brand-name-alcon-laboratories-inc-product-name-accessory-devices-for-unity-and-constellation-surgica/) Due to incomplete seals in the pouch which provide the sterile barrier. Class II Reported ongoing Distribution: Worldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, ... [Official source for Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0305-2026%22) Aug 5, 2025 FDA device enforcement ### [Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Prod...](https://isitonrecall.com/recall/fda-device-z-0306-2026-brand-name-alcon-laboratories-inc-product-name-accessory-devices-for-unity-and-constellation-surgica/) Due to incomplete seals in the pouch which provide the sterile barrier. Class II Reported ongoing Distribution: Worldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, ... [Official source for Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0306-2026%22) Aug 5, 2025 FDA device enforcement ### [Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Prod...](https://isitonrecall.com/recall/fda-device-z-0307-2026-brand-name-alcon-laboratories-inc-product-name-accessory-devices-for-unity-and-constellation-surgica/) Due to incomplete seals in the pouch which provide the sterile barrier. Class II Reported ongoing Distribution: Worldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, ... [Official source for Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0307-2026%22) Aug 5, 2025 FDA device enforcement ### [Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Prod...](https://isitonrecall.com/recall/fda-device-z-0308-2026-brand-name-alcon-laboratories-inc-product-name-accessory-devices-for-unity-and-constellation-surgica/) Due to incomplete seals in the pouch which provide the sterile barrier. Class II Reported ongoing Distribution: Worldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, ... [Official source for Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0308-2026%22) Apr 28, 2025 FDA device enforcement ### [Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' S...](https://isitonrecall.com/recall/fda-device-z-2108-2025-brand-name-alcon-laboratories-inc-product-name-constellation-vision-system-vitrectomy-procedure-pak/) 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 comprom... Class II Reported ongoing Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, N... [Official source for Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedu...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2108-2025%22) Apr 28, 2025 FDA device enforcement ### [Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Sof...](https://isitonrecall.com/recall/fda-device-z-2109-2025-brand-name-alcon-laboratories-inc-product-name-constellation-vision-system-combined-procedure-pak-mo/) 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 comprom... Class II Reported ongoing Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, N... [Official source for Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2109-2025%22) Apr 28, 2025 FDA device enforcement ### [Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: ...](https://isitonrecall.com/recall/fda-device-z-2110-2025-brand-name-alcon-laboratories-inc-product-name-custom-pak-model-catalog-number-many-see-attachment-1/) 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 comprom... Class II Reported ongoing Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, N... [Official source for Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'A...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2110-2025%22) Feb 10, 2025 FDA device enforcement ### [Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 804...](https://isitonrecall.com/recall/fda-device-z-1293-2025-alcon-custom-pak-with-non-latex-symbol-pak-12771-18-18050-10-18252-17-12698-09-15632-10-3141-45-1263/) Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the symbol for a latex-free product. If users or patients with latex sensitivity come into ... Class II Reported ongoing Distribution: US Nationwide distribution in the states of AK, AR, AZ, FL, MD, MN, NC, NE, OH, PA, TX, WA, WI. [Official source for Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 31...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1293-2025%22) Dec 18, 2024 FDA drug enforcement ### [Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134](https://isitonrecall.com/recall/fda-drug-d-0200-2025-systane-lubricant-eye-drops-ultra-pf-sterile-25-vials-0-7ml-each-manufactured-for-alcon-laboratories/) Non-Sterility Class I Reported ongoing Distribution: US Nationwide. [Official source for Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon La...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0200-2025%22) Nov 13, 2024 FDA device enforcement ### [Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D delivery cartridge Lens Guide, Intraocular...](https://isitonrecall.com/recall/fda-device-z-0835-2025-brand-name-alcon-product-name-monarch-iii-d-delivery-cartridge-model-catalog-number-8065977763-produ/) Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery. Class II Reported ongoing Distribution: US: AK AL AR AZ CA CO CT DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY OUS: Russia, Egypt [Official source for Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 806597776...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0835-2025%22) Oct 15, 2024 FDA device enforcement ### [a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, #...](https://isitonrecall.com/recall/fda-device-z-0490-2025-a-alcon-custom-pak-constellation-25g-plus-christiana-care-hlth-serv-15340-11-containing-tubing-salem/) Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made. Class III Reported ongoing Distribution: US distribution to states of: Delaware, Illinois, and Oklahoma [Official source for a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBI...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0490-2025%22) Aug 8, 2024 FDA device enforcement ### [DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,](https://isitonrecall.com/recall/fda-device-z-3313-2024-dailies-total1-dailies-total1-for-astigmatism-dailies-total1-multifocal-total30-sphere/) Material with a quality issue was used in contact lens production, so contact lenses may not meet quality and/or performance standards for the entirety of their labeled shelf life, and wearing these lenses may lead to temporary issues such as irritation, re... Class II Reported ongoing Distribution: US: UT, TX, NC, MT, AL, WA, MS, PA, LA, MI, GA, FL, KY, OH, AZ, IL, CA, NJ, TN, NY, AR, MN, WI, MD, OK, SC, OR, MA, CO, VA, CT, IA, DE, WV, MO, ID, SD, NE, NV, IN, ME, VT, NM, N... [Official source for DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3313-2024%22) Jul 15, 2024 FDA device enforcement ### [Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic knife Component: N/A](https://isitonrecall.com/recall/fda-device-z-2645-2024-product-name-clearcut-s-safety-sideport-knife-1-0mm-dual-bevel-model-catalog-number-8065771540-softw/) Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. Class II Reported ongoing Distribution: Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, ... [Official source for Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2645-2024%22) Jul 15, 2024 FDA device enforcement ### [Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System Component: N/A](https://isitonrecall.com/recall/fda-device-z-2646-2024-product-name-25ga-valved-entry-system-3ct-model-catalog-number-8065751658-software-version-n-a-produ/) Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. Class II Reported ongoing Distribution: Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, ... [Official source for Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2646-2024%22) ## Reasons in these listed records - Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. - Ophthalmic procedure packs may have incomplete seals affecting sterility. - Potential for a weak seal in some units resulting in compromise in sterility. - XXX These examples come from this result page and are not a ranking of every recall reason. ## Checking Alcon Research, LLC ### Is there a recall on alcon research, llc right now? This archive contains 66 records, including 66 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Alcon Research, LLC](https://isitonrecall.com/check/?q=Alcon%20Research%2C%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)