Alcon Research, Ltd. recalls
53 recalls in our records from 2012 to 2026: 50 FDA medical devices, 3 FDA drugs.
Recalls with full detail pages
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Alcon Research LLC medical device recall: Brand Name: Alcon Laboratories
Ophthalmic procedure packs may have incomplete seals affecting sterility.
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Alcon Research LLC drug recall: Systane Lubricant Eye Drops
Non-Sterility
Earlier and other recalls
These link to the official agency notice.
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Alcon Research LLC drug recall: Systane Official notice ↗
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
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Alcon Research LLC medical device recall: CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K Official notice ↗
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Alcon Research LLC medical device recall: Alcon PRECISION1 One-Day Contact Lenses Official notice ↗
Potential for a weak seal in some units resulting in compromise in sterility.
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Alcon Research LLC medical device recall: Brand Name: Alcon Laboratories Official notice ↗
Due to incomplete seals in the pouch which provide the sterile barrier.
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Alcon Research LLC medical device recall: Brand Name: Alcon Laboratories Official notice ↗
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While…
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Alcon Research LLC medical device recall: Alcon Custom Pak with Non-Latex Symbol Official notice ↗
Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the…
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Alcon Research LLC medical device recall: Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge… Official notice ↗
Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon…
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Alcon Research LLC medical device recall: a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV Official notice ↗
Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
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Alcon Research LLC medical device recall: Dailies Total1 Official notice ↗
Material with a quality issue was used in contact lens production, so contact lenses may not meet quality and/or performance standards for the entirety of their labeled…
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Alcon Research LLC medical device recall: Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel… Official notice ↗
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
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Alcon Research LLC medical device recall: Surgical Image Guidance Functionality Official notice ↗
After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect…
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Alcon Research LLC medical device recall: 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software… Official notice ↗
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
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Alcon Research, LLC medical device recall: Various Alcon Custom Paks Surgical Procedure Pack containing Oasis… Official notice ↗
Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas.
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Alcon Research, LLC medical device recall: Syringe Official notice ↗
Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgical procedure packs…
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Alcon Research, LLC medical device recall: Alcon Custom-Pak Official notice ↗
Custom surgical procedure packs contain latex gloves but are labeled as "latex free".
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Alcon Research, LLC medical device recall: Constellation Vision System Official notice ↗
Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component…
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Alcon Research, LTD. medical device recall: Constellation Procedure Pak Official notice ↗
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
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Alcon Research, LLC medical device recall: Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak… Official notice ↗
Sterility; Steril surgical procedure packs contain incomplete seals.
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Alcon Research, LLC medical device recall: Alcon Custom Pak Surgical Procedure Pack Official notice ↗
Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of…
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Alcon Research, LLC medical device recall: Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H… Official notice ↗
Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.
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Alcon Research, LLC medical device recall: Alcon Custom Ophthalmic Surgical Procedure Packs Official notice ↗
Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages.
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Alcon Research, LLC medical device recall: Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health"… Official notice ↗
The third-party brand latex micro surgical gloves packaged within specific custom packs may have a degradation defect that could lead to holes and donning tears at the…
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Alcon Research LLC medical device recall: Acrysof Official notice ↗
Incorrect IOL diopter
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Alcon Research LLC medical device recall: Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure… Official notice ↗
There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula.
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Alcon Research, LTD. medical device recall: CyPass System 241-S Official notice ↗
Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell…
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Alcon Research, LTD. medical device recall: Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items… Official notice ↗
Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT probe may…
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Alcon Research, LTD. medical device recall: Alcon Custom Pak Official notice ↗
Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the…
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Alcon Research, Ltd. medical device recall: LX3 Floor Stand for LuxOR Ophthalmic Microscope Official notice ↗
Multiple shipments or forceful impact to a caster on a LuxOr/LX3 microscope may stress the microscope base, which could contribute to a caster breaking or detaching from…
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Alcon Research, Ltd. medical device recall: ORA System with VerifEye+ Cart Official notice ↗
Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error…
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Alcon Research, Ltd. medical device recall: Alcon Patient Care Kits Product Usage: A Patient Care Kit is an… Official notice ↗
Alcon is initiating a Voluntary Medical Device Removal because the product supplier has stated that there is potential for sterile packaging to be compromised.
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Alcon Research, Ltd. medical device recall: Alcon Monarch III Official notice ↗
The intraocular lens could become lodged within the cartridge
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Alcon Research, Ltd. medical device recall: LAUREATE World Phaco System Official notice ↗
Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)
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Alcon Research, Ltd. medical device recall: Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage:… Official notice ↗
The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that could result in the IOL becoming lodged in the Delivery System
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Alcon Research, Ltd. medical device recall: CENTURION Vision System Official notice ↗
The grounding pin within the Power Entry Switch on certain systems was susceptible to detachment when the AC power cable is removed.
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Alcon Research, Ltd. medical device recall: Centurion Fms Official notice ↗
Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS packs due to the possible presence of a molding irregularity found…
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Alcon Research, Ltd. medical device recall: LenSx Laser System. Indicated for use in patients undergoing cataract… Official notice ↗
Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which…
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Alcon Research, Ltd. medical device recall: Alcon 23G and 25G Valved Entry System provides access into the… Official notice ↗
The product has potential to leak beyond their design specification.
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Alcon Research, Ltd. medical device recall: INFINITI Ultrasound Pack. Catalog Numbers: 8065751716 Official notice ↗
The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs.
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Alcon Research, Ltd. medical device recall: VERION Reference Unit Official notice ↗
Alcon is conducting a voluntary medical device correction of all VERION Reference Units (Vision Planner) that are shared with the Alcon LenSx Laser System after…
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Alcon Research, Ltd. drug recall: TEARS Naturale FREE Official notice ↗
Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the…
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Alcon Research, Ltd. medical device recall: of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric… Official notice ↗
Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL.
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Alcon Research, Ltd. medical device recall: Custom Pak 9319-27. Single-use medical devices and accessories… Official notice ↗
The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.
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Alcon Research, Ltd. medical device recall: LX3 Floor Stand for Endure Luxite Envision Optical System Official notice ↗
Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands after receiving reports concerning loss of functionality due to issues with the cabling between…
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Alcon Research, Ltd. medical device recall: ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon… Official notice ↗
There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.
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Alcon Research, Ltd. medical device recall: Accurus 2500 Standalone Vitreous Probe REF 8065741018 Official notice ↗
Insufficient seal on the outside packaging, potentially affecting the sterility of the product.
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Alcon Research, Ltd. medical device recall: The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of… Official notice ↗
The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves due to the potential for splits and holes on the glove. Should the user…
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Alcon Research, Ltd. medical device recall: Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101… Official notice ↗
The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.
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Alcon Research, Ltd. medical device recall: INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management… Official notice ↗
Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the aspiration line.
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Alcon Research, Ltd. medical device recall: eye-pak 7407 Tray Support Cover REF 8065740745 Official notice ↗
The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured.
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Alcon Research, Ltd. medical device recall: Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component… Official notice ↗
Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle
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Alcon Research, LTD. medical device recall: This voluntary medical device correction is related to Alcon products… Official notice ↗
This medical device correction is related to Alcon products that present a 23G non-valved trocar cannula and infusion cannula together because of an issue regarding the…
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.