Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge
Medical device recall Z-0835-2025. Published in FDA’s Enforcement Report on Jan 22, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 22, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 51 states named in where it went
- 41718 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D delivery cartridge Lens Guide, Intraocular Component: N/A
41718 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN/UDI 10380659777636/ Lot # 15895927 15895928 15895929 15895930 15895931 15895932 15895933 15895934 15895935 15895936 15895937 15895938 15895939 15895940 15895941 15895942 15895965 15895969 15895973 15895977 15899643 15899644 15899687…
Every code shown here, 1,993 characters
GTIN/UDI 10380659777636/ Lot # 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 15904031 15904032 15904033 15904034 15904035 15904036 15904037 15904038 15904039 15904040 15904041 15904042 15904043 15904045 15906851 15906852 15906853 15913832 15913833 15913834 15913835 15913836 15913837 15913838 15913839 15913840 15913841 15913842 15913846 15913850 15913855 15913859 15913862 15913919 15913920 15913921 15913922 15913923 15913924 15913925 15913926 15913927 15913928 15913929 15913930 15913931 15913932 15913933 15913934 15913935 15913936 15913937 15913938 15913939 15913940 15913941 15913942 15913943 15913944 15913945 15913946 15913947 15913948 15913949 15913950 15913951 15913952 15913953 15913954 15913955 15913956 15913957 15913958 15913959 15913961 15914064 15914065 15914066 15914067 15914068 15914069 15914119 15914120 15914121 15914123 15914124 15914126 15914128 15929038 15929039 15929040 15929041 15929042 15929044 15929045 15929198 15929199 15929200 15929201 15929202 15929203 15929204 15929205 15929206 15929207 15929208 15929209 15929210 15929211 15929212 15929213 15929214 15929215 15929216 15929217 15929218 15929219 15929220 15929221 15929222 15929223 15929224 15929225 15929226 15929227 15929228 15929229 15929230 15929231 15929232 15929233 15929234 15929235 15929236 15929237 15929238 15929265 15929285 15932682 15932683 15932684 15932685 15932686 15932687 15932688 15932689 15932690 15932691 15932692 15932693 15932694 15932695 15932696 15932697 15932698 15932699 15932700 15932701 15932702 15932703 15932704 15932705 15932706 15932707 15932708 15932709 15932710 15932711…
FDA’s list runs to 3,054 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
The states and territories these words name
51 states and territories.
Every one of them
- 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
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 13, 2024.
- FDA classified it on Jan 10, 2025.
- FDA’s Enforcement Report published it on Jan 22, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Alcon Research LLC, of Fort Worth, TX.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,054 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.