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.

1–25 of 40

  • SevereFDA (Devices)·Z-2406-2023·2023-08-23

    Alcon Constellation Procedure Pak recalled due to plastic debris risk

    Alcon is recalling the Constellation Procedure Pak due to reports of patient injury from plastic debris. The debris can result from over-tightening the device with the included plastic wrench.

    Product
    Constellation Procedure Pak
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2410-2023·2023-08-23

    Phaco Standalone Tips Recalled Due to Plastic Debris Risk

    Alcon is recalling 444,372 units of Phaco Standalone Tips worldwide because the plastic wrench included with the product can generate plastic debris when over-tightened, potentially injuring patients.

    Product
    Phaco Standalone Tips
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2408-2023·2023-08-23

    Infinity FMS Pak surgical device recalled for plastic debris hazard

    Alcon is recalling the Infinity FMS Pak surgical device after reports of patient injuries during procedures caused by plastic debris from over-tightening the included wrench. The recall affects 51,054 units distributed worldwide.

    Product
    Infinity FMS Pak
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2411-2023·2023-08-23

    Alcon Custom Pak Intraocular Lens Packages Recalled for Plastic Debris Risk

    Alcon Custom Pak intraocular lens packages are recalled due to reports of patient injury during surgical procedures caused by plastic debris from over-tightening with the included plastic wrench.

    Product
    Alcon Custom Pak
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2407-2023·2023-08-23

    Centurion FMS Pak Recalled Due to Patient Injury Risk from Plastic Debris

    Alcon Research recalls the Centurion FMS Pak following reports of patient injury during procedures. Plastic debris can result from over-tightening with the included plastic wrench.

    Product
    Centurion FMS Pak
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0188-2019·2018-10-31

    Alcon Recalls CyPass Micro-Stent Implant Due to Endothelial Cell Loss

    Alcon is recalling the CyPass Micro-Stent implant because long-term study data showed statistically significant endothelial cell loss in patients who received the device.

    Product
    CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. For ophthalmic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0185-2019·2018-10-31

    Alcon Recalls CyPass Micro-Stent Due to Endothelial Cell Loss

    Alcon Research is recalling CyPass Micro-Stent devices because long-term study data showed statistically significant endothelial cell loss in patients.

    Product
    CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0186-2019·2018-10-31

    Alcon Recalls CyPass Micro-Stent Implant Due to Endothelial Cell Loss

    Alcon is recalling the CyPass Micro-Stent implant because long-term study data showed statistically significant endothelial cell loss in patients.

    Product
    CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2019·2018-10-31

    Alcon Recalls CyPass Micro-Stent Due to Endothelial Cell Loss

    Alcon Research is recalling the CyPass Micro-Stent because long-term study data showed statistically significant endothelial cell loss in patients who received the device.

    Product
    CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0779-2018·2018-03-07

    Alcon Recalls 25+ TOTALPLUS Vitrectomy Pak Due to Probe Mismatch

    Alcon is recalling specific lots of the 25+ TOTALPLUS Vitrectomy Pak because a 23GA probe may be included instead of the required 25GA probe.

    Product
    Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a component.) Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0778-2018·2018-03-07

    Alcon 25+ TOTALPLUS Vitrectomy Pak Recalled for Incorrect Probe Inclusion

    Alcon is voluntarily recalling 300 units of the 25+ TOTALPLUS Vitrectomy Pak because a 23GA probe may be included instead of the required 25GA probe.

    Product
    Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3081-2017·2017-09-06

    Alcon Recalls LuxOR Ophthalmic Microscope Floor Stands Due to Caster Defect

    Alcon is recalling 1,074 LuxOR microscope floor stands because casters may break or detach from the base after impact or stress.

    Product
    LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope Floor Stands are not stand-alone medical devices, but are used in combination with the LuxOR Ophthalmic Microscope and the LuxOR Ophthalmic Microscope with Q-VUE 3-D Assista
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3050-2017·2017-08-30

    Alcon ORA System Recall for Incorrect IOL Power Measurements

    Alcon is recalling 367 ORA Systems with VerifEye because a software error may cause incorrect intraocular lens power measurements during cataract surgery.

    Product
    ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3049-2017·2017-08-30

    Alcon ORA System Recall for Incorrect IOL Power Measurements

    Alcon is recalling 429 ORA Systems with VerifEye+ Carts due to a software error that may cause incorrect intraocular lens power measurements during cataract surgery.

    Product
    ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1837-2017·2017-04-26

    Alcon Recalls Patient Care Kits Due to Sterile Packaging Concerns

    Alcon is voluntarily removing 561,702 Patient Care Kits from the US market because the supplier reported potential sterile packaging compromise.

    Product
    Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured with customer-specific components
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2017·2017-01-18

    Alcon Monarch III Cartridge Recalled Due to Potential Lens Lodging

    Alcon Research, Ltd. is recalling 1,130 Monarch III (1) "C" Cartridges because the intraocular lens could become lodged within the device.

    Product
    Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2708-2016·2016-09-07

    Alcon AcrySof IQ Intraocular Lens Recall Due to Delivery System Defect

    Alcon is recalling specific lots of AcrySof IQ intraocular lenses because the ULTRASERT delivery system may cause the lens to become lodged during implantation.

    Product
    Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior chamber lens for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients fol
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2081-2016·2016-07-06

    Alcon CENTURION Vision System Recalled for Power Switch Defect

    Alcon Research, Ltd. is recalling the CENTURION Vision System because the grounding pin in the power entry switch may detach when the AC power cable is removed.

    Product
    CENTURION Vision System
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1940-2016·2016-06-15

    Alcon Recalls CENTURION FMS Packs Due to Molding Irregularity

    Alcon is voluntarily removing specific lots of CENTURION FMS packs due to a molding irregularity that may reduce vacuum in the aspiration line.

    Product
    CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1688-2016·2016-05-25

    Alcon Recalls LenSx Lasers Due to Incomplete Corneal Flap Creation

    Alcon is voluntarily recalling 81 LenSx Laser Systems with Corneal Flap Capability due to reports of incomplete corneal flap creation during surgery.

    Product
    LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1694-2016·2016-05-25

    Alcon Recalls 23G and 25G Valved Trocar Cannula Custom Paks

    Alcon Research, Ltd. is recalling 30,701 units of 23G and 25G valved trocar cannula Custom Paks because the products have the potential to leak beyond their design specification.

    Product
    Custom Paks containing 23G and 25G valved trocar cannula provide 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
  • HighFDA (Devices)·Z-1693-2016·2016-05-25

    Alcon Recalls 23G and 25G Constellation Totalplus Paks for Potential Leakage

    Alcon Research, Ltd. is recalling 225,000 units of 23G and 25G Constellation Totalplus Paks because the products have the potential to leak beyond their design specifications.

    Product
    23G and 25G Constellation Totalplus Paks 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