Alcon Custom Ophthalmic Surgical Procedure Packs
Medical device recall Z-1328-2021. Published in FDA’s Enforcement Report on Apr 7, 2021.
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 Apr 7, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 249,853 Custom Packs 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?
Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Alcon Custom Ophthalmic Surgical Procedure Packs
249,853 Custom Packs, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Number Pak Number 2461031H 0012-61, 2461032H 0017-68, 2471522H 0017-69, 2470351H 0091-68, 2475039H 0091-69, 2477748H 0147-62, 2462158H 0148-63, 2460228H 0188-76, 2467978H 0204-58, 2462215H 0234-66, 2467189H 0234-66, 2469722H 0234-66,…
Every code shown here, 1,992 characters
Lot Number Pak Number 2461031H 0012-61, 2461032H 0017-68, 2471522H 0017-69, 2470351H 0091-68, 2475039H 0091-69, 2477748H 0147-62, 2462158H 0148-63, 2460228H 0188-76, 2467978H 0204-58, 2462215H 0234-66, 2467189H 0234-66, 2469722H 0234-66, 2469576H 0235-74, 2471338H 0235-74, 2476349H 0235-74, 2456156H 0316-66, 2451430H 0365-74, 2464636H 0437-38, 2466614H 0437-38, 2469145H 0437-38, 2475934H 0437-38, 2478372H 0437-38, 2465722H 0472-56, 2451167H 0486-69, 2457152H 0486-69, 2468378H 0540-73, 2477328H 0540-74, 2457720H 0557-75, 2459855H 0557-75, 2465117H 0557-75, 2467632H 0557-75, 2471693H 0557-75, 2450010H 0562-64, 2452620H 0562-64, 2465723H 0562-64, 2472329H 0562-64, 2448882H 0587-88, 2449035H 0587-88, 2450960H 0587-88, 2470118H 0587-88, 2465724H 0607-57, 2470245H 0613-80, 2475040H 0613-80, 2459856H 0630-68, 2465118H 0630-68, 2471694H 0630-68, 2474352H 0630-68, 2476843H 0630-68, 2458037H 0633-57, 2463374H 0633-57, 2457722H 0650-75, 2465119H 0650-75, 2467633H 0650-75, 2463375H 0680-72, 2457723H 0720-71, 2465120H 0720-71, 2461039H 0721-59, 2467033H 0721-59, 2473703H 0721-60, 2458813H 0773-66, 2454401H 0774-65, 2465665H 0800-70, 2470205H 0800-70, 2461040H 0802-62, 2464915H 0802-62, 2467274H 0802-62, 2474132H 0802-62, 2457153H 0835-59, 2470095H 0847-86, 2470096H 0847-86, 2448883H 0849-75, 2450961H 0849-75, 2460231H 0849-75, 2470131H 0849-75, 2458038H 0888-68, 2475890H 0888-68, 2464512H 0933-71, 2469459H 0933-71, 2469460H 0933-71, 2473935H 0933-71, 2473936H 0933-71, 2469461H 0938-57, 2473937H 0938-58, 2457154H 0956-67, 2459858H 0979-64, 2477374H 10008-15, 2452698H 10014-60, 2465653H 10030-16, 2470316H 10030-16, 2470849H 10030-16, 2476257H 10039-17, 2443135H 1007-67, 2448974H 1007-67, 2450962H 1007-67, 2458399H 1007-67, 2459860H 10104-13, 2462847H 10104-13, 2465123H 10104-13, 2474357H 10104-13, 2464850H 10111-18, 2469645H 10111-18, 2476415H 10111-18, 2476416H 10111-18, 2462312H 1011-59, 2462593H 1011-59, 2449036H 10136-15, 2450963H 10136-15, 2458400H 10136-15, 2448940H…
FDA’s list runs to 178,913 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.
Distribution US nationwide, including Puerto Rico; Canada, Australia, New Zealand, Mexico, Malaysia, and Thailand
The states and territories these words name
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Feb 2, 2021.
- FDA classified it on Apr 1, 2021.
- FDA’s Enforcement Report published it on Apr 7, 2021.
- FDA terminated it on Jun 30, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Alcon Research, LLC, of Houston, 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 178,913 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
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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.