Alcon Research LLC recalls
Every recall we track for Alcon Research LLC — 70 in all, from 2018–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Alcon Research LLC fell by more than half in 2025 (12, down from 47 in 2024).
All FDA recall records for Alcon Research LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 1 | 0 | 1 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 1 | 1 | 0 | 2 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 0 | 2 | 0 | 2 |
| 2023 | 0 | 1 | 2 | 0 | 3 |
| 2024 | 0 | 28 | 18 | 1 | 47 |
| 2025 | 0 | 2 | 9 | 1 | 12 |
| 2026 (to date) | 0 | 0 | 2 | 0 | 2 |
Most common reasons for Alcon Research LLC recalls
What to do if you have a recalled Alcon Research LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Alcon Research LLC recalls
25 shown- Lower riskDrug
Alcon Research LLC recalls GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth,
Alcon recalls sterile GenTeal Tears eye gel due to potential lack of sterility. Products distributed by Alcon Laboratories with specific lot numbers and expiration dates are affected. Consumers should check their product details and contact Alcon for guidance.
AlconApr 21, 2026 - Lower riskMedical device
Alcon Research LLC recalls Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03,
Alcon recalls Custom Pak surgical procedure packs with incomplete seals that could lead to contamination during ophthalmic surgery. Affected models include 9903-20, 17188-04, 19762-03, 19203-04, and 17957-10. Owners should check lot numbers for affected batches.
Alcon LaboratoriesNov 24, 2025 - Use cautionMedical device
Alcon Research LLC recalls Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
Alcon is recalling specific lots of PRECISION1 One-Day Contact Lenses due to potential weak seals that may compromise sterility. Check your lot number.
AlconSep 30, 2025 - UnratedMedical device
Alcon Research LLC recalls CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/
Alcon Research LLC recalls Constellation Ultravit 10K and Constellation Hypervit 20K products due to unspecified hazard. Check your product's serial number against the list to see if it's affected.
Alcon ResearchSep 15, 2025 - Lower riskMedical device
Alcon Research LLC recalls Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles
Alcon recalls accessory devices for Unity and Constellation surgical consoles due to incomplete sterile pouch seals that could lead to contamination during vitrectomy procedures. Affected models include specific catalog numbers and batch numbers listed in the recall notice.
Alcon LaboratoriesAug 5, 2025 - Lower riskMedical device
Alcon Research LLC recalls Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog
Alcon recalls specific lots of Constellation Vision System Vitrectomy Procedure Paks due to potential sterility compromise from manufacturing damage. Affected units include various model numbers and lot codes listed in Attachment 1.
AlconApr 28, 2025 - Use cautionMedical device
Alcon Research LLC recalls Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07,
Alcon recalls custom surgical packs with a latex-free symbol that may contain latex. If you have latex sensitivity, contact Alcon for a replacement.
AlconFeb 10, 2025 - Lower riskDrug
Alcon Research LLC recalls Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth
Alcon recalls Systane Lubricant Eye Drops (25 vials) due to non-sterility risk. Consumers should check lot numbers and contact Alcon for details.
AlconDec 18, 2024 - Lower riskMedical device
Alcon Research LLC recalls Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description:
Alcon recalls Monarch III D delivery cartridges with a molding defect that may scratch intraocular lenses during surgery. Affected units have specific model numbers and lot codes.
AlconNov 13, 2024 - Lower riskMedical device
Alcon Research LLC recalls a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR;
Alcon recalls specific Custom-Pak products with tubing Anti-Reflux Valves that may break due to improper use. Affected units include models from Christiana Care Health Serv, Mercy Hospital, and Illinois Masonic Med Ctr. No remedy is stated in the recall notice.
AlconOct 15, 2024 - Lower riskMedical device
Alcon Research LLC recalls DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
Alcon is recalling DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, and TOTAL30 Sphere contact lenses produced with a material quality issue that may cause temporary irritation, redness, or blurred vision.
AlconAug 8, 2024 - Use cautionMedical device
Alcon Research LLC recalls Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992561 Software Version: N/A Product
Alcon recalls specific ClearCut SB Intrepid 2.2 ANG ophthalmic knives due to increased reports of sharpness issues. Affected models include catalog number 8065992561. Consumers should check their product details.
AlconJul 15, 2024 - Lower riskMedical device
Alcon Research LLC recalls Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
Alcon recalls specific software for NGENUITY 3D Visualization System (part 8065000399) due to potential incorrect IOL axis placement after eye surgery. Affected units have serial numbers listed in the recall.
AlconMay 23, 2024 - Lower riskMedical device
Alcon Research LLC recalls ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product
Alcon recalls specific ClearCut S Safety Sideport Knives due to sharpness complaints. Affected models have catalog number 8065771541. Consumers should check if their knife matches the listed details.
AlconApr 22, 2024 - Lower riskMedical device
Alcon Research, LLC recalls Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom
Alcon recalls various Custom Paks Surgical Procedure Packs containing Oasis 27Ga Chang Hydrodissection Cannulas due to complaints of particulates, residue, occlusions, and bent tips. These packs are used by ophthalmic surgeons in eye surgeries.
AlconMar 15, 2024 - Use cautionMedical device
Alcon Research, LLC recalls SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products:
Alcon recalls specific bulb syringes used in surgical procedures due to potential breach of sterile packaging, increasing infection risk if reused after opening.
AlconFeb 21, 2024 - Lower riskMedical device
Alcon Research, LLC recalls Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
Alcon recalls surgical procedure packs labeled 'latex free' that actually contain latex gloves. This could cause allergic reactions in sensitive users. Check product details to see if you have the affected items.
AlconSep 7, 2023 - Use cautionMedical device
Alcon Research, LLC recalls Constellation Vision System, REF: 8065751150
Alcon recalls Constellation Vision System (REF: 8065751150) due to a PCB design flaw that may cause loss of pressure control, increasing infection risk. Affected units have specific serial numbers.
AlconAug 18, 2023 - Lower riskMedical device
Alcon Research, LLC recalls Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT
Alcon recalls surgical procedure packs with incomplete sterilization seals that could lead to infections. Affected packs have specific lot numbers and expiration dates.
AlconMar 10, 2023 - Lower riskMedical device
Alcon Research, LLC recalls Alcon Custom Pak Surgical Procedure Pack
Alcon recalls certain Custom Pak Surgical Procedure Packs due to difficulty removing adhesive liners, which may render the product unusable. The manufacturer has also observed an increase in adhesive-related skin injuries with these affected lots.
AlconOct 31, 2022 - Lower riskMedical device
Alcon Research, LLC recalls Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF
Alcon recalls surgical procedure packs that include latex gloves, which are supposed to have non-latex gloves. Affected packs were sold to eye surgery centers in the US. Consumers should check product labels for specific batch numbers.
AlconJun 9, 2022 - Lower riskMedical device
Alcon Research, LLC recalls Alcon Custom Ophthalmic Surgical Procedure Packs
Alcon Research LLC
Alcon Research LLCFeb 2, 2021 - Use cautionMedical device
Alcon Research, LLC recalls Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product
Alcon Research recalls specific Custom-Pak Surgical Procedure Packs containing PROTEXIS latex micro surgical gloves due to potential holes at cuff folds that could increase infection or cross-patient exposure risk.
Alcon ResearchAug 24, 2020 - Lower riskMedical device
Alcon Research LLC recalls Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY
Alcon recalls Acrysof IQ IOLs with incorrect diopter settings that may cause vision issues. Affected models include 20.5 D SP ACRYLIC FOLDABLE LENS with UltraSert delivery system. Contact Alcon for details.
AlconApr 17, 2020 - Lower riskMedical device
Alcon Research LLC recalls Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name
Alcon recalls 20 GA Totalplus Procedure Pak (Product #8065751079) due to possible inclusion of 25-gauge cannula instead of 20-gauge, which could cause incorrect surgical procedures.
AlconJul 25, 2018
Alcon Research LLC recall questions
How many recalls has Alcon Research LLC had?
70 recalls from Alcon Research LLC are on record with U.S. safety agencies, from 2018–2026 (67 medical device, 3 drug).
What is the most recent Alcon Research LLC recall?
Alcon Research LLC recalls GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth,, dated Apr 21, 2026. Every Alcon Research LLC recall is listed on this page, newest first.
Why are Alcon Research LLC products recalled?
The most common reasons on record: Due to incomplete seals in the pouch which provide the sterile barrier. (5).
What should I do if I have a recalled Alcon Research LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Alcon Research LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.