Lower risk Medical device recall · FDA · Published November 13, 2024

Alcon Monarch III D Delivery Cartridge Recall: Scratches on Intraocular Lenses

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0835-2025Medical device Alcon ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmAlcon Research LLC6201 South Fwy · Fort Worth, TX 76134-2099

✎ GovInfoNow plain-language explainer

Alcon is recalling Monarch III D delivery cartridges due to a molding defect that could scratch intraocular lenses during surgery. This defect may cause complications for patients undergoing cataract surgery. Read more at govinfonow.com/recall/53501-alcon-monarch-iii-d-delivery-cartridge-recall-scratches-on-intraocular.

Source Summary by GovInfoNow · govinfonow.com/recall/53501-alcon-monarch-iii-d-delivery-cartridge-recall-scratches-on-intraocular · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0835-2025

Cite this page

“Alcon Monarch III D Delivery Cartridge Recall: Scratches on Intraocular Lenses.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53501-alcon-monarch-iii-d-delivery-cartridge-recall-scratches-on-intraocular. Based on FDA recall #Z-0835-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0835-2025%22&limit=1).

The FDA announced on Nov. 13, 2024, that Alcon Research LLC voluntarily recalled Monarch III D Delivery Cartridges due to a molding defect that could scratch intraocular lenses. The agency issued recall number Z-0835-2025 for the Class II device.

How to tell if you have it

Brand: Alcon
Product Name: Monarch III D Delivery Cartridge
Model/Catalog Number: 8065977763
Lot codes: 15895927 through 15895942, 15895965, 15895969, 15895973, 15895977, 15899643-15899644, 15899687-15899693, 15899695-15899698, 15899700-15899701, 15899730-15899738, 15899753, 15904026-15904043, 15904045, 15906851-15906853, 15913832-15913842, 15913846, 15913850, 15913855, 15913859, 15913862, 15913919-15913961, 15914064-15914069, 15914119-15914121, 15914123, 15914124, 15914126, 15914128, 15929038-15929042, 15929044-15929045, 15929198-15929238, 15929265, 15929285, 15932682-15932713, 15932715, 15932716, 15932718, 15932720, 15933058-15933103, 15933104-15933109, 15933110, 15933112, 15933172-15933177, 15933243-15933257, 15933260-15933281, 15933350-15933367, 15944530-15944532, 15944534-15944535, 15950090-15950096

The hazard

The recall addresses an increase in complaints associated with a molding defect within the inner lumen of delivery cartridges. This defect could result in a scratch on the intraocular lens upon delivery.

Context

GovInfoNow's records show Alcon Research LLC has issued 24 other recalls since July 25, 2018. Recent Alcon recalls include a GenTeal Tears Eye Gel recall for lack of sterility assurance on April 21, 2026, and an Alcon Custom Pak sterility risk recall on Nov. 24, 2025. Other recent recalls of similar products include Covidien V-Loc 90 Wound Closure Device Recall (June 24, 2026), Covidien V-Loc 180 Absorbable Wound Closure Device Recall (June 24, 2026), and Covidien Dermalon 4-0 Blue 75cm Sutures Recall (June 24, 2026).

How to tell if you have this one

Check if your Monarch III D delivery cartridge has the model number 8065977763 and lot numbers from 15895927 to 15944535 as listed in the recall notice.

Brand
Alcon
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify your cartridge's model number (8065977763) and lot numbers (15895927-15944535) to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed in 49 states.

FDA distribution: “US: 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 MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY OUS: Russia, Egypt” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 2 months after the firm started it.

Nov 13, 2024Firm started the recall
Jan 10, 2025FDA classified it Class II
Jan 22, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/53501-alcon-monarch-iii-d-delivery-cartridge-recall-scratches-on-intraocular">Alcon Monarch III D Delivery Cartridge Recall: Scratches on Intraocular Lenses (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0835-2025 (November 13, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0835-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.