Alcon Research, Ltd.

Complete recall history across all FDA and CPSC categories — 40 total recalls

Alcon Research, Ltd. appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (1)

FDA drug safety enforcement actions by Alcon Research, Ltd.

Date Product Reason Class
Feb 9, 2016 TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1... Lack of Assurance of Sterility: Some single-use vials may be filled with wate... Class II

Device Recalls (39)

FDA medical device enforcement actions by Alcon Research, Ltd.

Date Product Reason Class
Jun 28, 2023 Alcon Custom Pak Reports of patient injury during use in procedures due to potential for plast... Class II
Jun 28, 2023 Phaco Standalone Tips Reports of patient injury during use in procedures due to potential for plast... Class II
Jun 28, 2023 Infinity FMS Pak Reports of patient injury during use in procedures due to potential for plast... Class II
Jun 28, 2023 Constellation Procedure Pak Reports of patient injury during use in procedures due to potential for plast... Class II
Jun 28, 2023 Legion FMS Pak Reports of patient injury during use in procedures due to potential for plast... Class II
Jun 28, 2023 Centurion FMS Pak Reports of patient injury during use in procedures due to potential for plast... Class II
Aug 28, 2018 CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT,... Analysis of the completed dataset from the COMPASS-XT long-term study showed ... Class I
Aug 28, 2018 CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065... Analysis of the completed dataset from the COMPASS-XT long-term study showed ... Class I
Aug 28, 2018 CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT,... Analysis of the completed dataset from the COMPASS-XT long-term study showed ... Class I
Aug 28, 2018 CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF C... Analysis of the completed dataset from the COMPASS-XT long-term study showed ... Class I
Jan 12, 2018 Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a c... Alcon is conducting this Voluntary Medical Device Recall for a specific lot (... Class II
Jan 12, 2018 Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a c... Alcon is conducting this Voluntary Medical Device Recall for a specific lot (... Class II
Aug 8, 2017 Alcon Custom Pak Alcon is initiating a medical device recall, after receiving notification fro... Class II
Jun 30, 2017 ORA System with VerifEye, Catalog Number 8065998300 For use during intraocul... Some ORA Carts have the potential to return an incorrect IOL power measuremen... Class II
Jun 30, 2017 ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during int... Some ORA Carts have the potential to return an incorrect IOL power measuremen... Class II
May 25, 2017 LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmi... Multiple shipments or forceful impact to a caster on a LuxOr/LX3 microscope m... Class II
Mar 27, 2017 Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblag... Alcon is initiating a Voluntary Medical Device Removal because the product su... Class II
Sep 5, 2016 Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySo... The intraocular lens could become lodged within the cartridge Class II
Jul 28, 2016 Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Al... The ULTRASERT Delivery System from certain lots have an inferior surface char... Class II
Jul 28, 2016 LAUREATE World Phaco System Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU) Class II
May 24, 2016 CENTURION Vision System The grounding pin within the Power Entry Switch on certain systems was suscep... Class II
Apr 28, 2016 CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision Syst... Alcon is conducting this Voluntary Medical Device Removal for specific lots o... Class II
Apr 14, 2016 LenSx Laser System. Indicated for use in patients undergoing cataract surger... Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap ... Class II
Mar 1, 2016 VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Gu... Alcon is conducting a voluntary medical device correction of all VERION Refer... Class II
Sep 29, 2015 Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric... Continued increase in reports of post-operative inflammation in patients who ... Class I
Sep 21, 2015 Custom Pak 9319-27. Single-use medical devices and accessories designed by m... The recalled lot of custom paks are labeled as latex free and contain latex g... Class II
Aug 11, 2015 LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue... Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands aft... Class II
Aug 11, 2015 Alcon 23G and 25G Valved Entry System provides access into the posterior segm... The product has potential to leak beyond their design specification. Class II
Aug 11, 2015 Custom Paks containing 23G and 25G valved trocar cannula provide access into ... The product has potential to leak beyond their design specification. Class II
Aug 11, 2015 23G and 25G Constellation Totalplus Paks provides access into the posterior s... The product has potential to leak beyond their design specification. Class II
Jun 2, 2015 Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalo... Insufficient seal on the outside packaging, potentially affecting the sterili... Class II
Apr 28, 2015 The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use... The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, r... Class II
Apr 15, 2015 ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcryS... There are reports of post - operative inflammation and/or toxic anterior segm... Class I
Nov 11, 2014 Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile ... The product is sold and labeled as EO sterilized, however the units were not ... Class II
Oct 30, 2014 INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. S... Alcon is conducting a medical device recall due to the possible presence of p... Class II
Oct 6, 2014 INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718... The recalling firm received complaints related to leakage from the tubing nea... Class II
Jun 3, 2014 eye-pak 7407 Tray Support Cover REF 8065740745 The peel pouches of the Tray Support Covers may be insufficiently sealed so t... Class II
May 16, 2014 Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Numbe... Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula ... Class II
May 29, 2012 This voluntary medical device correction is related to Alcon products that pr... This medical device correction is related to Alcon products that present a 23... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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