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.

51–70 of 70

  • HighFDA (Devices)·Z-2656-2024·2024-08-28

    Ophthalmic Surgical Knives Recalled Due to Sharpness Issues

    Alcon Research LLC is recalling certain ophthalmic knives (20 Gauge V-Lance model) due to complaints about sharpness. The affected units may not function properly during eye surgery.

    Product
    Product Desc: Product Name: 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
  • HighFDA (Devices)·Z-2664-2024·2024-08-28

    Ophthalmic knife sharpness defect recalled for increased complaints

    Alcon recalls 3,419 ophthalmic knives due to increased complaints about blade sharpness. The Class II recall affects the ClearCut SB INTREPID 2.2 ANG and related models distributed nationwide and internationally.

    Product
    Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992561 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2673-2024·2024-08-28

    Alcon Ophthalmic Surgical Knives Recalled for Sharpness Defects

    Alcon recalls TOTAL PLUS ophthalmic surgical knives due to sharpness defect complaints. The 3,197 affected units are distributed nationwide and internationally.

    Product
    Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2658-2024·2024-08-28

    Alcon ClearCut and A-OK Ophthalmic Knives Recalled for Reduced Sharpness

    Alcon is recalling ClearCut Sideport and A-OK Corneal/Scleral V-Lance ophthalmic knives due to reports of reduced blade sharpness. The recall affects 6,020 units distributed in the United States and internationally.

    Product
    Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065982465 Software Version: N/A Product Description: Ophthalmic knife 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-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
  • 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-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-1606-2024·2024-05-01

    Alcon Custom Paks Surgical Procedure Packs recalled for cannula defects

    Alcon is recalling Custom Paks Surgical Procedure Packs containing Oasis 27Ga Chang Hydrodissection Cannulas due to complaints of particulates, residue, occlusions, and bent tips in sterile cannulas used in ophthalmic surgery.

    Product
    Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons in a variety of ophthalmic surgeries. The Custom Pak is a collection of various ophthalmic surgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1370-2024·2024-04-03

    Alcon bulb irrigation syringes recalled due to sterile barrier compromise

    Alcon is recalling bulb irrigation syringes due to potential sterile barrier compromise in surgical procedure packs. Non-sterile syringes may increase infection risk.

    Product
    SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66, 5675-76,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0260-2024·2023-11-15

    Surgical Procedure Pack Contains Latex Despite 'Latex-Free' Label

    Alcon Custom-Pak surgical procedure packs contain latex gloves but are labeled as 'latex-free,' posing an allergic reaction risk for healthcare workers and patients with latex allergies.

    Product
    Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0099-2024·2023-10-18

    Constellation Vision System surgical units recalled for pressure control defect

    Alcon Research recalls Constellation Vision System ophthalmic microsurgical units due to a printed circuit board design flaw that could disable pressure control, risking infection and tissue damage.

    Product
    Constellation Vision System, REF: 8065751150
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1291-2023·2023-04-05

    Alcon Custom Pak Surgical Procedure Packs Recalled for Incomplete Seals

    Alcon Research is recalling 1,035 Custom Pak Surgical Procedure Packs with incomplete seals that affect sterility. These packs were distributed to surgical facilities in 14 US states.

    Product
    Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR 1913
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0354-2023·2022-12-07

    Alcon Surgical Procedure Packs Recalled for Adhesive Defect and Skin Injuries

    Alcon is recalling Custom Pak Surgical Procedure Packs because the adhesive liner is difficult to remove and the manufacturer has observed an increase in skin injuries related to the adhesive.

    Product
    Alcon Custom Pak Surgical Procedure Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1373-2022·2022-07-20

    Alcon Custom Pak Surgical Procedure Packs recalled for incorrect latex gloves

    Alcon has recalled 320 kits of Custom Pak Surgical Procedure Packs distributed across Arizona, California, Missouri, and New York because they contain latex gloves instead of the specified non-latex gloves, creating an allergen hazard for sensitive patients.

    Product
    Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1328-2021·2021-04-07

    Alcon Custom Ophthalmic Surgical Procedure Packs Recalled for Mold

    Alcon is recalling 249,853 custom ophthalmic surgical procedure packs because mold was found on gowns included in the packages.

    Product
    Alcon Custom Ophthalmic Surgical Procedure Packs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0095-2021·2020-10-21

    Alcon Custom-Pak Surgical Packs Recalled for Latex Glove Degradation

    Alcon is recalling 16,971 Custom-Pak Surgical Procedure Packs containing Cardinal Health PROTEXIS Latex Micro Surgical Gloves due to a degradation defect that could cause holes or tears.

    Product
    Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2287-2020·2020-06-17

    Alcon Recalls AcrySof IQ Intraocular Lenses Due to Incorrect Diopter

    Alcon Research LLC is recalling 84 units of AcrySof IQ intraocular lenses because they have an incorrect diopter. The lenses were distributed nationwide.

    Product
    Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1794-2020·2020-04-29

    Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak Recall

    Alcon Research LLC is recalling 102 sterile procedure packs due to a potential mix-up with a 25-gauge infusion cannula.

    Product
    Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
    Category
    Medical Device
    Distribution
    0 states