Brand Name: Alcon Laboratories, Inc
Medical device recall Z-2108-2025. 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
- 198205 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: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See ‘Attachment 1 - Affected Product List’ Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A
198205, 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’ Product Description: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU Catalog Number: 8065000093 UDI-DI code: 380650000934 Lot Numbers: 177FE4 1782JM 178DEX 178TCV 179EP4 179EP3 179U0P…
Every code shown here, 2,000 characters
Lot Code: Many - See ‘Attachment 1 - Affected Product List’ Product Description: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU Catalog Number: 8065000093 UDI-DI code: 380650000934 Lot Numbers: 177FE4 1782JM 178DEX 178TCV 179EP4 179EP3 179U0P 17AVMM 17AVMN 17AVML 17AVMP Product Description: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Catalog Number: 8065000095 UDI-DI code: 380650000958 Lot Numbers: 1782JU 1782JT 178DF2 178TCY 178TD0 1792YF 1792YE 179U0R 17A4XT 17A4XU 17AFXT 17AVMT 17AVMU 17AVMV 17AVMW 17AVMX 17CNVC Product Description: 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU Catalog Number: 8065000096 UDI-DI code: 380650000965 Lot Numbers: 1782JV 178DF4 17A4XV Product Description: TOTAL PLUS,23G,10K VALVE STD Catalog Number: 8065752435 UDI-DI code: 380657524358 Lot Numbers: 1754N7 1754NC 175M43 1762KH 176CCJ 176CCK 176WU8 176WU9 17769X 1782HM 1782HN 178T9K 179EEV 179TY3 179TY4 17A4WX 17C7FM 17C7FL Product Description: TOTAL PLUS,23GA,10K VALVE WD Catalog Number: 8065752436 UDI-DI code: 380657524365 Lot Numbers: 1762KJ 176WUA 17769Y 177FDH 1782HP 178DE8 178T9N 179EEX 179EEY 17C7FK Product Description: TOTAL PLUS,25+,10K VALVE STD Catalog Number: 8065752437 UDI-DI code: 380657524372 Lot Numbers: 1754NK 1754NL 1754NM 1754TC 1754TD 1754TE 1754TF 1754TH 175M45 175M46 175M47 175M44 1762KK 1762KL 1762KM 1762KN 176CCR 176CCL 176CCM 176CCN 176CCP 176WUD 1776A4 1776A5 1776A6 177FDJ 177FDK 177FDL 177FDM 177TUP 177TUR 177TUT 1782HU 1782HV 1782HW 178DEA 178DEC 178T9V 178T9W 178TD4 17930F 17930H 179EF3 179EF2 179TY6 179TY7 179TY8 179TY9 179TYA 179TYC 179TYD 17A4X5 17A4X6 17A4X2 17A4X3 17A4X1 17AFWE 17AFWH 17AFWP 17AFWR 17AFWY 17AFX0 17AFWX 17C7FD 17C7FE Product Description: TOTAL PLUS,25+,10K VALVE WD Catalog Number: 8065752438 UDI-DI code: 380657524389 Lot Numbers: 175M48 1762KR 1762KT 176CCT 176WUE 1776AD 177FDN 1782HY 178TA1 178TA2 178TA3 179EF6 179EF7 179TYJ 17A4X9 17AFX6 17C7FC 17CNUT Product Description: TOTAL PLUS,27+,10K VALVE STD Catalog Number: 8065752439 UDI-DI code: 380657524396 Lot…
FDA’s list runs to 3,786 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 3,786 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.