The Recall Desk

Manufacturer

Alcon Research, LTD.

40 recalls in our database name Alcon Research, LTD. as the manufacturing or recalling firm.

What the numbers show

Total
40
Critical
2
Severe
7
Most recent
2023-08-23

Of the 40 recalls from Alcon Research, LTD. we have scored against our rubric, 2 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 7 (18%) 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.

26–40 of 40

  • HighFDA (Devices)·Z-1692-2016·2016-05-25

    Alcon Valved Entry System Recalled for Potential Leakage

    Alcon Research, Ltd. is recalling 83,448 units of 23G and 25G Valved Entry Systems because they may leak beyond design specifications.

    Product
    Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1597-2016·2016-05-11

    Alcon Recalls INFINITI Ultrasound Packs Due to Tubing Leakage

    Alcon Research is recalling INFINITI Ultrasound Packs because the irrigation line tubing may leak near the white luer.

    Product
    INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1394-2016·2016-04-20

    Alcon Recalls VERION Reference Units Due to Surgical Plan Errors

    Alcon is voluntarily recalling 97 VERION Reference Units because unplanned arcuate lines may appear on printed or exported surgical plans.

    Product
    VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed to provide greater accuracy and efficiency during cataract surgery. It allows eye surgeons to capture a high-resolut
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0666-2016·2016-02-24

    Alcon Recalls TEARS Naturale FREE Eye Drops Due to Sterility Concerns

    Alcon is recalling TEARS Naturale FREE eye drops because some vials may contain water instead of the product, creating a sterility risk.

    Product
    TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.03 FL OZ) Single-Use Vials, packaged in 60-count Single-Use Vials per carton, Manufactured for: Alcon Laboratories, Inc., Fort Work, TX 76134, Barcode 9001674110
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0271-2016·2015-12-02

    Alcon AcrySof IQ Toric IOL Recall Expanded for Post-Operative Inflammation

    Alcon Research, Ltd. is expanding a recall of AcrySof IQ Toric intraocular lenses due to increased reports of post-operative inflammation in patients.

    Product
    Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0195-2016·2015-11-11

    Alcon Custom Pak 9319-27 Recalled for Latex Glove Mislabeling

    Alcon Research, Ltd. is recalling five units of Custom Pak 9319-27 ophthalmic surgical devices because they contain latex gloves despite being labeled as latex-free.

    Product
    Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2448-2015·2015-09-02

    Alcon Recalls LX3 Microscope Floor Stands Due to Cabling Issues

    Alcon is voluntarily recalling LX3 Microscope Floor Stands because cabling issues may cause loss of functionality or illumination failure.

    Product
    LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product Usage: The LX3 Microscope Floor Stand is an accessory to the LuxOR Opthalmic Microscope and the LuxOR Opthalmic Microscope with Q-VUE 3-D Assistant Visualization and provides a portable sus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2323-2015·2015-08-19

    Alcon ReSTOR Intraocular Lenses Recalled for Post-Operative Inflammation Reports

    Alcon Research, Ltd. is recalling ReSTOR intraocular lenses manufactured for Japan due to reports of post-operative inflammation and toxic anterior segment syndrome (TASS). No US distribution occurred.

    Product
    ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1940-2015·2015-07-08

    Alcon Accurus Vitreous Probes Recalled for Packaging Seal Defect

    Alcon Research is recalling Accurus vitreous probes due to insufficient outer packaging seals that may compromise sterility.

    Product
    Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only. Intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1702-2015·2015-06-10

    Alcon Custom Pak Recalled for Potential Glove Splits and Holes

    Alcon Research, Ltd. is recalling Alcon Custom Paks because the Devon Light Glove component may have splits or holes, which could lead to surgical site infections.

    Product
    The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0527-2015·2014-12-17

    Alcon Single-Use Iris Bipolar Forceps Recalled for Lack of Sterilization

    Alcon Research, Ltd. is recalling single-use iris bipolar forceps labeled as sterile but not sterilized prior to shipment.

    Product
    Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument for ophthalmic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0506-2015·2014-12-10

    Alcon Recalls INFINITI Vision System Ultrasound FMS Due to Tubing Debris

    Alcon is recalling INFINITI Vision System Ultrasound FMS units because pieces of tubing may be present in the aspiration line.

    Product
    INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE. Model Numbers: 8065741080, 8065741081, 8065741082, 8065741083, 8065741085, 8065741087, 8065741088, 8065741089, 8065741093, 8065741096, 8065741097, 8065741099, 8065750266, 8065750268, 8065750
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2694-2014·2014-10-01

    Alcon Recalls Eye-Pak 7407 Tray Support Covers Due to Seal Issues

    Alcon Research, Ltd. is recalling 2,462 Eye-Pak 7407 Tray Support Covers because insufficiently sealed peel pouches may compromise sterility.

    Product
    eye-pak 7407 Tray Support Cover REF 8065740745
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1947-2014·2014-07-09

    Alcon Anterior Chamber Cannula Recall Due to Incorrect Component

    Alcon is recalling CUSTOM-PAKs that contain a sharp tip needle instead of the intended anterior chamber cannula.

    Product
    Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2470-2012·2012-10-03

    Alcon 23G Ophthalmic Cannula Recall Due to Loose Fit

    Alcon is recalling 23G non-valved trocar and infusion cannulas due to a loose fit that could cause detachment during ophthalmic surgery.

    Product
    This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Const
    Category
    Medical Device
    Distribution
    Distributed nationwide