Alcon Research recalls
22 official recalls and safety alerts involving Alcon Research since 2022-07, from FDA · Device, FDA · Drug. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Alcon Research or the relevant agency.
- 2026-05-06
USAlcon Research LLC recalls GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC:…
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
- 2025-12-31
- US
Alcon Research LLC recalls Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04,…
Ophthalmic procedure packs may have incomplete seals affecting sterility.
FDA · DeviceAlcon Research LLCUS Nationwide distribution in the states of CA, ND, UT.Official notice → - 2025-12-03
- US
Alcon Research LLC recalls CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+…
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FDA · DeviceAlcon Research LLCWorldwide - US Nationwide distribution including in the states of PA, MN, CA,…Official notice → - 2025-11-05
- US
Alcon Research LLC recalls Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
Potential for a weak seal in some units resulting in compromise in sterility.
FDA · DeviceAlcon Research LLCWorldwide - US distribution in the states of Alabama, Arizona, Arkansas,…Official notice → - US
Alcon Research LLC recalls Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number:…
Due to incomplete seals in the pouch which provide the sterile barrier.
FDA · DeviceAlcon Research LLCWorldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE,…Official notice → - 2025-07-16
- US
Alcon Research LLC recalls Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See…
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 the damage in the lidding is visibly noticeable,…
FDA · DeviceAlcon Research LLCWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - 2025-03-12
- US
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, 18925-05, 19265-05,…
Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the symbol for a latex-free product. If users or…
FDA · DeviceAlcon Research LLCUS Nationwide distribution in the states of AK, AR, AZ, FL, MD, MN, NC, NE,…Official notice → - 2025-01-22
- US
Alcon Research LLC recalls Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D…
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 delivery.
FDA · DeviceAlcon Research LLCUS: AK AL AR AZ CA CO CT DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO…Official notice → - US
- 2024-11-27
- US
Alcon Research LLC recalls a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon…
Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
FDA · DeviceAlcon Research LLCUS distribution to states of: Delaware, Illinois, and OklahomaOfficial notice → - 2024-10-09
- US
Alcon Research LLC recalls DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
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 shelf life, and wearing these lenses may lead to…
FDA · DeviceAlcon Research LLCUS: UT, TX, NC, MT, AL, WA, MS, PA, LA, MI, GA, FL, KY, OH, AZ, IL, CA, NJ,…Official notice → - 2024-08-28
- US
Alcon Research LLC recalls Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992561 Software Version: N/A Product Description:…
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.
FDA · DeviceAlcon Research LLCDomestic: Nationwide Distribution Countries Affected: Argentina, Australia,…Official notice → - 2024-07-24
- US
Alcon Research LLC recalls Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registration angle, range indicator will…
FDA · DeviceAlcon Research LLCWorldwide - US Nationwide distribution including in the states of AL, AR, CA,…Official notice → - 2024-06-05
- US
Alcon Research LLC recalls ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic…
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.
FDA · DeviceAlcon Research LLCWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2024-05-01
- US
Alcon Research, LLC recalls Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical…
Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas.
FDA · DeviceAlcon Research, LLCWorldwide distribution - U.S. Nationwide including in the states of AK, AR,…Official notice → - 2024-04-03
- US
Alcon Research, LLC recalls SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44,…
Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgical procedure packs that were subsequently terminally sterilized, so…
- 2023-11-15
- US
Alcon Research, LLC recalls Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
Custom surgical procedure packs contain latex gloves but are labeled as "latex free".
- 2023-10-18
- US
Alcon Research, LLC recalls Constellation Vision System, REF: 8065751150
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 failure and loss of pressure control for the use of…
- 2023-08-23
- US
Alcon Research, LTD. recalls Centurion FMS Pak
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
FDA · DeviceAlcon Research, LTD.Worldwide distribution - US Nationwide and the countries of Aland Islands,…Official notice → - 2023-04-05
- US
Alcon Research, LLC recalls Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR…
Sterility; Steril surgical procedure packs contain incomplete seals.
FDA · DeviceAlcon Research, LLCUS: AL, AR, CA, IA, ID, IN, KY, MN, NC, ND, NJ, OH, PA, TX, OUS: NoneOfficial notice → - 2022-12-07
- US
Alcon Research, LLC recalls Alcon Custom Pak Surgical Procedure Pack
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 the drapes has observed an increase in reported…
FDA · DeviceAlcon Research, LLCWorldwide Distribution: U.S.(nationwide) to states of: AK, AL, AR, AZ, CA, CO,…Official notice → - 2022-07-20
- US
Alcon Research, LLC recalls Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL…
Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.