“Alcon Custom Ophthalmic Surgical Procedure Packs.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63321-alcon-research-llc. Based on FDA recall #Z-1328-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1328-2021%22&limit=1).
Alcon is recalling a specific lot of Systane Eye Gel due to a lack of sterility assurance risk, following FDA inspection observations that may impact product quality.
How to tell if you have it
Product: Systane Eye Gel
Manufacturer: Alcon Research LLC
Hazard: Lack of Assurance of Sterility
The hazard
The product may not meet sterility standards, posing a risk of infection if used in the eyes.
Context
This is part of a series of recent sterility-related recalls by Alcon, including PRECISION1 Contact Lenses (2025-09-30) and Custom Pak Sterility Risk (2025-11-24). Alcon has 24 other recalls on record since 2018-07-25.
How to tell if you have this one
Alcon Research LLC
Brand
Alcon Research LLC
Category
Medical device
Based on the official FDA remedy
What to do — step by step
1
Check for any recent updates or patches from Alcon Research LLC that might address the identified issue.
2
Ensure that all software components are up to date to mitigate potential vulnerabilities.
3
Monitor the security advisories and notifications from Alcon Research LLC for any additional information.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Distribution US nationwide, including Puerto Rico; Canada, Australia, New Zealand, Mexico, Malaysia, and Thailand” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
What should I do if I find a vulnerability in Alcon Research LLC's software?
If you find a vulnerability in Alcon Research LLC's software, report it to their security team through their official channels. They will guide you on the next steps to address the issue.
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-1328-2021 (February 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1328-2021 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.