Recall archive
14 recalls · page 1 of 1
Reported May 6, 2026
Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
Matched: Brand · Product · Product details — Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Dec 31, 2025
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Alcon Research LLC
Matched: Brand · Product · Product details — Ophthalmic procedure packs may have incomplete seals affecting sterility.
FDA (openFDA device enforcement)
Reported Dec 3, 2025
CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
Matched: Brand — XXX
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
Matched: Brand · Product · Product details — Due to incomplete seals in the pouch which provide the sterile barrier.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 16, 2025
Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
Matched: Brand · Product · Product details — 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…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
Matched: Brand · Product · Product details — Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent…
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
Matched: Brand · Product · Product details — Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2024
a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR;…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Alcon Research LLC
Matched: Brand · Product · Product details — Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
FDA (openFDA device enforcement)
Reported Oct 9, 2024
DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
Matched: Brand — Material with a quality issue was used in contact lens production, so contact lenses may not meet quality and/or performance standards for the…
FDA (openFDA device enforcement)
Reported Aug 28, 2024
Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
Matched: Brand · Reason for recall — Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance…
35 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
Matched: Brand — After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause…
FDA (openFDA device enforcement)
Reported Jun 5, 2024
20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
Matched: Brand · Reason for recall — Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 17, 2020
Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
Matched: Brand — Incorrect IOL diopter
FDA (openFDA device enforcement)
Reported Apr 29, 2020
Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
Matched: Brand · Product · Product details — There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula.
FDA (openFDA device enforcement)
RecallNow is not a government agency. Every notice above is published by the FDA, USDA FSIS, or CPSC and links back to its source. Back to the look-up