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Lower risk Medical device recall · FDA · Published May 23, 2024

Alcon Surgical Image Guidance Software Recall: Incorrect IOL Placement Risk

Alcon recalls specific software for NGENUITY 3D Visualization System (part 8065000399) due to potential incorrect IOL axis placement after eye surgery. Affected units have serial numbers listed in the recall.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2412-2024Medical deviceAlcon ›
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Contact the company

Recalling firmAlcon Research LLCAspex Facility, 6201 South Fwy · Fort Worth, TX 76134-2099
✎ GovInfoNow plain-language explainer

Alcon is recalling a specific software component used with their NGENUITY 3D Visualization System. If eye movement occurs during surgery, the software may display incorrect registration angles, potentially causing improper IOL placement and vision issues. Read more at govinfonow.com/recall/55024-alcon-surgical-image-guidance-software-recall-incorrect-iol-placement-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/55024-alcon-surgical-image-guidance-software-recall-incorrect-iol-placement-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2412-2024

Cite this page

“Alcon Surgical Image Guidance Software Recall: Incorrect IOL Placement Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55024-alcon-surgical-image-guidance-software-recall-incorrect-iol-placement-risk. Based on FDA recall #Z-2412-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2412-2024%22&limit=1).

Alcon Research LLC recalled Surgical Image Guidance Functionality software used with the NGENUITY 3D Visualization System after the FDA announced the recall on May 23, 2024. The software anomaly may cause incorrect placement of toric IOL axis during surgery.

How to tell if you have it

  • Brand: Alcon
  • Product: Surgical Image Guidance Functionality software used with NGENUITY 3D Visualization System
  • Part Number: 8065000399
  • UDI-DI: 00380650003997
  • Software Version: 1.5
  • Serial Numbers: 004-0680001 through 004-0680362, 004-0680404, 004-0680417, 004-0680418, 005-7230003 through 005-7230186, 007-4610018 through 007-4610409, 009-4570001 through 009-4570510, DM550021, DM550024, DM550043, DM550051, DM550054

The hazard

The FDA said that if significant eye rotation or movement occurs after surgery initiation, a software anomaly may cause re-establishment of an incorrect new registration angle. This error displays an incorrect range indicator, which could result in incorrect placement of the toric IOL axis and astigmatic error under- or over-correction. These issues could cause decreased uncorrected visual acuity.

Context

GovInfoNow's records show Alcon Research LLC has 24 other recalls on record since July 25, 2018. Other recent recalls of similar products include Alcon GenTeal Tears Eye Gel Recall (April 21, 2026), Alcon Custom Pak Sterility Risk (Nov. 24, 2025), and Almon Recalls PRECISION1 Contact Lenses Due to Sterility Risk (Sept. 30, 2025). Other recent recalls of similar products include Staar ICL Software Version 8.00 (April 20, 2026), GE Medical Systems Imactis CT-Navigation System Recall (Feb. 3, 2026), and Alphatec LIF NAV Osteotome 10mm (Jan. 2, 2026).

How to tell if you have this one

Check if your NGENUITY 3D Visualization System software has serial numbers listed in the recall (e.g., 004-0680001, 004-0680002, etc.). The software version is 1.5. The part number is 8065000399.

  • Brand
    Alcon
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your software version is 1.5 by checking the device settings or documentation.

  2. Contact Alcon for Details

    Reach out to Alcon directly to confirm if your specific serial number is affected and get instructions.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 33 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide - US Nationwide distribution including in the states of AL, AR, CA, CO, CT, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, TN, TX, WA, WI, PR and the countries of Canada, Japan,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Washington, Wisconsin.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: May 23, 202412. FDA classified it Class II: Jul 18, 202423. Published in FDA’s Enforcement Report: Jul 24, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Alcon Research LLC recalls GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth,
April 21, 2026

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2412-2024 (May 23, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2412-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA