PlainRecalls

Alcon Research, Ltd.

29 recalls on record · Latest: Aug 23, 2023

Alcon Research, Ltd. Recall Insight

Alcon Research, Ltd. appears on 29 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.035% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Aug 23, 2023, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 29 entries, severity tagging shows 3 critical, 26 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 29 of 29 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 2 distinct product categories, with issuing agencies dominated by FDA Devices (28), FDA Drug (1). The date window on this page runs from Jul 9, 2014 to Aug 23, 2023.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Aug 23, 2023

Centurion FMS Pak

FDA Devices Moderate Aug 23, 2023

Legion FMS Pak

FDA Devices Moderate Aug 23, 2023

Constellation Procedure Pak

FDA Devices Moderate Aug 23, 2023

Infinity FMS Pak

FDA Devices Moderate Aug 23, 2023

Alcon Custom Pak

FDA Devices Moderate Aug 23, 2023

Phaco Standalone Tips

FDA Devices Critical Oct 31, 2018

CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.

FDA Devices Critical Oct 31, 2018

CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.

FDA Devices Moderate Mar 7, 2018

Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.

FDA Devices Moderate Mar 7, 2018

Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a component.) Includes all necessary items for a core vitrectomy procedu…

FDA Devices Moderate Nov 8, 2017

Alcon Custom Pak

FDA Devices Moderate Sep 6, 2017

LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope Floor Stands are not stand-alone medical d…

FDA Devices Moderate Aug 30, 2017

ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery

FDA Devices Moderate Aug 30, 2017

ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery

FDA Devices Moderate Jul 6, 2016

CENTURION Vision System

FDA Devices Moderate May 25, 2016

23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 2…

FDA Devices Moderate May 25, 2016

Custom Paks containing 23G and 25G valved trocar cannula provide access into the posterior segment of the eye for surgical instruments within the fra…

FDA Devices Moderate May 25, 2016

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 …

FDA Devices Moderate May 25, 2016

LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.

FDA Devices Moderate May 11, 2016

INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical syste…

FDA Devices Moderate Apr 20, 2016

VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance techn…

FDA Drug Moderate Feb 24, 2016

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, pac…

FDA Devices Critical Dec 2, 2015

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…

FDA Devices Moderate Nov 11, 2015

Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.

FDA Devices Moderate Sep 2, 2015

LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product Usage: The LX3 Microscope Floor Stand is an accessory to t…

FDA Devices Moderate Jun 10, 2015

The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for s…

FDA Devices Moderate Dec 10, 2014

INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE. Model Numbers: 8065741080, 8065741081, 8065741082, 8065741083…

FDA Devices Moderate Oct 1, 2014

eye-pak 7407 Tray Support Cover REF 8065740745

FDA Devices Moderate Jul 9, 2014

Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 1333…

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds