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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Alcon Monarch III D Delivery Cartridges Recalled for Molding Defects

Agency Publication Date: January 10, 2025
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Summary

Alcon Research LLC has recalled 41,718 units of the Monarch III D Delivery Cartridge (Model 8065977763) due to a molding defect in the device's inner tube. This defect can cause scratches on an intraocular lens (IOL) as it is being delivered into a patient's eye during surgery. The manufacturer initiated the voluntary recall after an increase in complaints regarding these damaged lenses.

Risk

The molding defect can permanently scratch the intraocular lens during surgical implantation, which may impair the patient's vision or require the surgeon to use a replacement lens, potentially extending the duration of the surgery. Scratched lenses have been reported in multiple complaints.

What You Should Do

  1. This recall involves Alcon Monarch III D Delivery Cartridges, catalog number 8065977763, which are used to guide intraocular lenses during eye surgery.
  2. Affected units can be identified by the GTIN 10380659777636 and the lot number printed on the device packaging. See the Affected Products section below for the full list of affected codes.
  3. Stop using any recalled cartridges immediately to avoid damaging lenses during surgery.
  4. Contact Alcon Research LLC or your clinical equipment distributor to arrange for the return and replacement of the defective cartridges.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for more information or to report a problem with the device.

Your Remedy Options

📋Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Alcon Monarch III D Delivery Cartridge
Model / REF:
8065977763
Lot Numbers (336):
15895927
15895928
15895929
15895930
15895931
15895932
15895933
15895934
15895935
15895936
15895937
15895938
15895939
15895940
15895941
15895942
15895965
15895969
15895973
15895977
15899643
15899644
15899687
15899688
15899689
15899690
15899691
15899692
15899693
15899695
15899696
15899697
15899698
15899700
15899701
15899730
15899731
15899732
15899733
15899734
15899735
15899736
15899737
15899738
15899753
15904026
15904027
15904028
15904029
15904030
UDI:
10380659777636
GTIN:
10380659777636

Lens Guide, Intraocular Component

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95903
Status: Active
Manufacturer: Alcon Research LLC
Sold By: Authorized medical supply distributors; Surgical centers; Ophthalmic hospitals
Manufactured In: United States
Units Affected: 41718 units
Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.