Recall Register

Alcon Research LLC: FDA recalls

FDA enforcement reports name Alcon Research LLC as the recalling firm in 25 events. The events have 70 product records. The recalls started from 2018 to 2026.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

25 events, newest first.

FDA enforcement events of Alcon Research LLC
InitiatedProduct (first record)TypeClassRecordsStatus
21 Apr 2026Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01DrugClass II2Ongoing
24 Nov 2025Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic…DeviceClass I1Ongoing
30 Sep 2025Alcon PRECISION1 One-Day Contact Lenses, -2.25D.DeviceClass II1Ongoing
15 Sep 2025CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096; 23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413; 25+ BEVEL ULTRAVIT 10,000 CPM/ 8065752415;…DeviceClass II1Ongoing
5 Aug 2025Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE 8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROBE 8065753179 UNITY 25+ HYPERVIT 30K VIT…DeviceClass II5Ongoing
28 Apr 2025Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/ADeviceClass II3Ongoing
10 Feb 2025Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-17, 14764-09, 13194-16, 17069-09DeviceClass II1Ongoing
18 Dec 2024Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134DrugClass I1Ongoing
13 Nov 2024Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch III D delivery cartridge Lens Guide, Intraocular Component: N/ADeviceClass II1Ongoing
15 Oct 2024a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61…DeviceClass III1Ongoing
8 Aug 2024DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,DeviceClass II1Ongoing
15 Jul 2024Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic knife Component: N/ADeviceClass II36Ongoing
23 May 2024Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399DeviceClass II1Ongoing
22 Apr 202420 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/ADeviceClass II4Ongoing
15 Mar 2024Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons in a variety of ophthalmic surgeries. The Custom Pak is a collection of various ophthalmic surgical instruments and necessary materials.…DeviceClass II1Ongoing
21 Feb 2024SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66, 5675-76, 5918-39, 9208-66, 15190-16, 9065-25,…DeviceClass II1Ongoing
7 Sep 2023Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTRDeviceClass II1Ongoing
18 Aug 2023Constellation Vision System, REF: 8065751150DeviceClass II1Ongoing
10 Mar 2023Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR 19136-03 OCCULOPLASTIC WILMINGTON EYE 18401-03…DeviceClass II1Ongoing
31 Oct 2022Alcon Custom Pak Surgical Procedure PackDeviceClass II1Ongoing
9 Jun 2022Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LTRW GANS BASIC PACK NOVAMED EYE SURG CTR…DeviceClass II1Ongoing
2 Feb 2021Alcon Custom Ophthalmic Surgical Procedure PacksDeviceClass II1Terminated
24 Aug 2020Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.DeviceClass II1Terminated
17 Apr 2020Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.DeviceClass II1Terminated
25 Jul 2018Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Alcon Research LLC: events for each product type
TypeEvents
Device23
Drug2
Alcon Research LLC: events in each class
ClassEvents
Class II22
Class I2
Class III1
Share of the events of the firm in Class I
8%
Share of all events on the register in Class I
18%
Events with the status Ongoing
21

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Alcon Research LLC, by the year that the recall started. The largest year is 2024, with 9 events.

Official channels

Cite this page

Recall Register. Alcon Research LLC: FDA recalls. https://recallregister.com/firm/alcon-research-llc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
TX, CA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Alcon Research LLC have?
Class II: 22 events. Class I: 2 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
Which product types do the FDA recalls of Alcon Research LLC have?
Device: 23 events. Drug: 2 events.
What is the newest FDA recall of Alcon Research LLC?
FDA event 98815, which the firm started on 21 Apr 2026. The first product in the record is: Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01
How many FDA recalls of Alcon Research LLC have the status Ongoing?
21 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.