The Recall Desk

Manufacturer

Alcon Research LLC

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

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.

51–58 of 58

  • 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
  • HighFDA (Devices)·Z-2648-2024·2024-08-28

    Alcon ophthalmic surgical knives recalled for blade sharpness defects

    Alcon is recalling specific ophthalmic surgical knives (ClearCut and A-OK models) from its Custom Pak system due to blade sharpness complaints affecting 384,851 units distributed nationwide and internationally.

    Product
    Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2678-2024·2024-08-28

    Alcon ophthalmic surgical knives recalled for sharpness defects

    Alcon is recalling ClearCut and A-OK ophthalmic surgical knives due to sharpness complaints. The defect affects 1,057 units distributed nationwide and internationally.

    Product
    Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2412-2024·2024-07-24

    Surgical Image Guidance Software May Cause Incorrect Toric IOL Axis Placement

    Surgical image guidance software in NGENUITY 3D systems may miscalculate lens axis placement during eye rotation, potentially causing astigmatic error and decreased visual acuity.

    Product
    Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1923-2024·2024-06-05

    ClearCut and A-OK ophthalmic surgical knives recalled for sharpness issues

    Alcon is recalling ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance ophthalmic surgical knives due to increased complaint reports about sharpness. Approximately 427,764 units are affected worldwide.

    Product
    ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1925-2024·2024-06-05

    Ophthalmic surgical knives recalled due to sharpness complaints

    Alcon is recalling ClearCut S Safety Sideport Knife (1.2mm Dual Bevel) due to increased reports of sharpness issues. The recall affects 4,930 units distributed worldwide.

    Product
    ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1924-2024·2024-06-05

    Alcon ClearCut S and A-OK ophthalmic surgical knives recalled for sharpness defects

    Alcon is recalling about 19,867 ClearCut S and A-OK ophthalmic surgical knives worldwide due to an increase in complaints about blade sharpness.

    Product
    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
  • HighFDA (Devices)·Z-1922-2024·2024-06-05

    Ophthalmic surgical knives recalled for sharpness defects

    Alcon is recalling approximately 29,190 V-Lance ophthalmic surgical knives due to reports of blade sharpness defects. Affected instruments are distributed worldwide, including as components in Alcon Custom Pak surgical procedure packs.

    Product
    20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide