Brand Name: Alcon Laboratories, Inc
Medical device recall Z-2110-2025. Published in FDA’s Enforcement Report on Jul 16, 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 Jul 16, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 50 states named
- 15557 kits 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?
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 of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See ‘Attachment 1 - Affected Product List’ Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
15557 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Code: Many - See ‘Attachment 1 - Affected Product List’ Catalog Number / Lot Number / Custom Pak Description/ UDI-DI code: 0094-77 17C3H9 J-CAT PAK - CVS KENRITSU NINOHE HP 380655137888 10366-13 17CY90 AUS-CATARACT BRISBANE WATERS…
Every code shown here, 1,998 characters
Lot Code: Many - See ‘Attachment 1 - Affected Product List’ Catalog Number / Lot Number / Custom Pak Description/ UDI-DI code: 0094-77 17C3H9 J-CAT PAK - CVS KENRITSU NINOHE HP 380655137888 10366-13 17CY90 AUS-CATARACT BRISBANE WATERS 380655161951 10924-15 176JX0 25G VIT 25G OPTICARE EYE HLTH CTR 380651690714 11201-11 17A18R AUS-DR CH KHONG ST JOHN OF GOD GERALDTON 380655184899 11201-11 17A1AW AUS-DR CH KHONG ST JOHN OF GOD GERALDTON 380655184899 11220-27 176NYN VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 1772HN VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 1772L9 VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 177URH VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 179TKU VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17CF2K VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17AMJJ VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17AMMW VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17CLCN VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 179Y3T VITRECTOMY 25G NORTHSIDE HOSP 380655178492 1137-65 17A46H CATARACT FRENCH HOSP CORP 380653436938 1137-65 17CXY9 CATARACT FRENCH HOSP CORP 380653436938 12568-09 178PTE 23G CONSTELLATION NORTHERN MICH SPPLY AL 380653414561 12568-09 17CK02 23G CONSTELLATION NORTHERN MICH SPPLY AL 380653414561 12641-14 178KD6 AUS-25GA VIT RET BRISBANE WATERS 380655181935 12852-16 179N1E AUS-23GA 10K COMBINED VR PAK NEW CHILDRE 380655158425 13110-11 17AKR3 23GA CVS RETINA TPP V A HOSP HOUSTON 380655177549 13501-08 177DMP 23G VIT CONSTELLATION LOMA LINDA COMM HO 380653441505 13501-08 178423 23G VIT CONSTELLATION LOMA LINDA COMM HO 380653441505 13501-08 178N3H 23G VIT CONSTELLATION LOMA LINDA COMM HO 380653441505 13501-08 178UD9 23G VIT CONSTELLATION LOMA LINDA COMM HO 380653441505 13501-08 17AHCE 23G VIT CONSTELLATION LOMA LINDA COMM HO 380653441505 13501-08 17AX1V 23G VIT CONSTELLATION LOMA LINDA COMM HO 380653441505 13501-08 17CCAH 23G VIT CONSTELLATION LOMA LINDA COMM HO 380653441505 13502-10 17703Y 25+G…
FDA’s list runs to 50,602 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.
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Ecuador, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Luxembourg, Macao, Malaysia, Malta, Mexico, Moldova, Mongolia, Montenegro, Morocco, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Qatar, Republic of North Macedonia, R¿union, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam.
The states and territories these words name
50 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
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.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 Apr 28, 2025.
- FDA classified it on Jul 10, 2025.
- FDA’s Enforcement Report published it on Jul 16, 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 50,602 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.