The Recall Desk

Manufacturer

Alcon Research, LLC

70 recalls in our database name Alcon Research, LLC as the manufacturing or recalling firm.

What the numbers show

Total
70
Critical
1
Severe
3
Most recent
2026-05-06

Of the 70 recalls from Alcon Research, LLC we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (4%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 70

  • SevereFDA (Drugs)·D-0491-2026·2026-05-06

    Systane Lubricant Eye Gel Recalled Due to Sterility Concerns

    Alcon Research LLC is recalling Systane Lubricant Eye Gel Night Gel (10g) distributed nationwide due to FDA inspection observations regarding lack of assurance of sterility that may impact product quality.

    Product
    SYSTANE — SYSTANE (HYPROMELLOSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0492-2026·2026-05-06

    GenTeal Tears Lubricant Eye Gel Recalled Due to Sterility Concerns

    Alcon Research LLC is recalling GenTeal Tears Lubricant Eye Gel nationwide due to FDA inspection observations indicating the product may lack assurance of sterility. Consumers should not use affected lots.

    Product
    GENTEAL TEARS — GENTEAL TEARS (HYPROMELLOSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0939-2026·2025-12-31

    Ophthalmic surgical packs recalled over incomplete seals affecting sterility

    Alcon Research is recalling 151 Custom Pak ophthalmic procedure packs because the packs may have incomplete seals affecting sterility. The FDA has classified the action as Class I.

    Product
    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 Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience k
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0581-2026·2025-12-03

    Vitrectomy probe packs recalled with no reason stated in the record

    Alcon Research is recalling 28,323 Constellation UltraVit 10K and HyperVit 20K vitrectomy probe packs; the enforcement record does not state a reason.

    Product
    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; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096; 23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413; 25+ B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0305-2026·2025-11-05

    Infusion line packs recalled over incomplete seals in sterile pouches

    Alcon Research is recalling 25,778 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0307-2026·2025-11-05

    Chandelier illuminators recalled over incomplete seals in the sterile pouch

    Alcon Research is recalling 330 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000252 UNITY 27 GA CHANDELIER 8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE Softwa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0306-2026·2025-11-05

    Surgical console accessories recalled over incomplete seals in sterile pouches

    Alcon Research is recalling six accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000393 UNITY HP VISCOUS FLUID CONTROL VFC PACK Software Version: N/A Product Descr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0308-2026·2025-11-05

    Entry system accessories recalled over incomplete seals in sterile pouches

    Alcon Research is recalling 1,632 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0304-2026·2025-11-05

    Vitrectomy probe accessories recalled over incomplete seals in sterile pouches

    Alcon Research is recalling 577 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE 8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0326-2026·2025-11-05

    Daily contact lenses recalled over a weak seal compromising sterility

    Alcon Research is recalling 82 units of PRECISION1 One-Day Contact Lenses in -2.25D because some units may have a weak seal that compromises sterility.

    Product
    Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2108-2025·2025-07-16

    Alcon Constellation vitrectomy packs may have damaged lidding compromising sterility

    Alcon Constellation Vision System Vitrectomy Procedure Paks are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 198,205 units affected.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constella
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2110-2025·2025-07-16

    Alcon Custom Pak surgical kits may have damaged lidding compromising sterility

    Alcon Custom Paks, customer-designed sterile surgical kits, are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 15,557 kits affected.

    Product
    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: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intende
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2025·2025-07-16

    Alcon Constellation procedure packs may have damaged lidding compromising sterility

    Alcon Constellation Vision System Combined Procedure Paks are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 89,495 units affected.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1293-2025·2025-03-12

    Alcon Custom Pak surgical packs mislabeled as latex-free despite containing latex

    Alcon surgical procedure packs contain latex but are labeled as latex-free, creating risk of allergic reaction for patients with latex sensitivity. The company is recalling 2,511 affected units.

    Product
    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, 8043-29, 12466-17, 15599-17, 14764-09, 13194-16, 17069-09
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0200-2025·2025-01-22

    Systane Lubricant Eye Drops Recalled for Non-Sterility Risk

    Alcon Research is voluntarily recalling Systane Lubricant Eye Drops, Ultra PF, due to non-sterility concerns. The recall affects 55,960 boxes distributed nationwide.

    Product
    Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0835-2025·2025-01-22

    Alcon Monarch III D Delivery Cartridge Recalled for Molding Defect Risk

    Alcon is recalling 41,718 units of its Monarch III D Delivery Cartridge due to a molding defect that could scratch the intraocular lens during cataract surgery.

    Product
    Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D delivery cartridge Lens Guide, Intraocular Component: N/A
    Category
    Medical Device
    Distribution
    51 states
  • ModerateFDA (Devices)·Z-0490-2025·2024-11-27

    Alcon anti-reflux valve tubing breakage recall due to improper use

    Alcon Research LLC is recalling its Custom-Pak anti-reflux valve tubing because breakage occurred from improper use, resulting in updated labeling requirements.

    Product
    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, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-3313-2024·2024-10-09

    Alcon contact lenses recalled for manufacturing quality defect

    Alcon is recalling approximately 92,835 packs of contact lenses because a material quality issue may affect lens performance standards. Wearers may experience temporary eye irritation, redness, or blurred vision.

    Product
    DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2670-2024·2024-08-28

    Alcon Recalls ClearCut Ophthalmic Knives Due to Reduced Sharpness

    Alcon is recalling 15,222 units of ClearCut Slit and A-OK ophthalmic knives due to reports of reduced sharpness. The devices are distributed nationwide and internationally across 45+ countries.

    Product
    Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Catalog Number: 8065993047 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2659-2024·2024-08-28

    Ophthalmic Surgical Knives Recalled for Reduced Sharpness in Eye Surgery

    Alcon Research LLC is recalling 2,520 CLEARCUT HP2 DB ophthalmic knives due to increased reports of reduced sharpness. The affected lot 164RY1 was distributed nationwide and internationally.

    Product
    Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number: 8065983065 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2671-2024·2024-08-28

    Ophthalmic Surgical Knives Recalled Due to Sharpness Defect

    Alcon is recalling 7,713 units of ClearCut and A-OK ophthalmic surgical knives due to reports of decreased sharpness. The defect may compromise surgical performance during eye procedures.

    Product
    Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2651-2024·2024-08-28

    Ophthalmic knives recalled for sharpness defects in ClearCut Safety Intrepid DB

    Alcon is recalling 1,152 ClearCut Safety Intrepid DB 2.2 ophthalmic knives (Model 8065772265) due to complaint reports of sharpness defects.

    Product
    Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2 Model/Catalog Number: 8065772265 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2655-2024·2024-08-28

    Alcon A-OK Ophthalmic Knife Recalled for Sharpness Defect

    Alcon is recalling A-OK ophthalmic knives due to an increase in reports of sharpness defects. The affected knives are used in eye surgery and may not perform as intended.

    Product
    Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2669-2024·2024-08-28

    Alcon Ophthalmic Surgical Knives Recalled Over Reported Sharpness Issues

    Alcon is recalling 11,676 ophthalmic surgical knives due to increased reports of sharpness defects. Affected units were distributed nationwide and internationally.

    Product
    Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Catalog Number: 8065993045 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2645-2024·2024-08-28

    ClearCut S Safety Sideport Knife Recalled for Decreased Sharpness

    Alcon Research LLC is recalling ClearCut S Safety Sideport Knife ophthalmic surgical instruments due to reports of decreased sharpness. Affected units may not perform as intended during eye surgery.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide