Alcon Custom Pak Sterility Risk: Incomplete Seals May Cause Contamination
Alcon recalls Custom Pak surgical procedure packs with incomplete seals that could lead to contamination during ophthalmic surgery. Affected models include 9903-20, 17188-04, 19762-03, 19203-04, and 17957-10. Owners should check lot numbers for affected batches.
Lower-risk recall
Ophthalmic procedure packs may have incomplete seals affecting sterility.
Contact the company
What happened, in plain English
Alcon Laboratories is recalling Custom Pak surgical procedure packs that may have incomplete seals, risking contamination during eye surgery. This could lead to infections or other complications if the packs are not sterile. Read more at govinfonow.com/recall/50616-alcon-custom-pak-sterility-risk-incomplete-seals-may-cause-contamination.
Source Summary by GovInfoNow · govinfonow.com/recall/50616-alcon-custom-pak-sterility-risk-incomplete-seals-may-cause-contamination · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0939-2026
Cite this page
“Alcon Custom Pak Sterility Risk: Incomplete Seals May Cause Contamination.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50616-alcon-custom-pak-sterility-risk-incomplete-seals-may-cause-contamination. Based on FDA recall #Z-0939-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0939-2026%22&limit=1).
Why it’s dangerous
The seals on the Custom Pak packs may not be fully closed, which could allow contamination during surgery. This poses a risk of infection or complications if the packs are not sterile when used.
Who’s affected
Trained ophthalmic surgeons who use Custom Pak surgical packs for eye procedures. Those with the specific model numbers and lot numbers listed are most at risk.
How to tell if you have this one
Check the model numbers: 9903-20, 17188-04, 19762-03, 19203-04, or 17957-10. Look for lot numbers: 17PJ9X, 17PJAY, 17PU09, 17PMWE, 17PTXP, or 17PTXY.
- Brand
Alcon Laboratories- Category
Medical device
What to do — step by step
Check Model Numbers
Identify the model numbers on your Custom Pak pack: 9903-20, 17188-04, 19762-03, 19203-04, or 17957-10.
Check Lot Numbers
Check the lot numbers: 17PJ9X, 17PJAY, 17PU09, 17PMWE, 17PTXP, or 17PTXY.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
FDA distribution: “US Nationwide distribution in the states of CA, ND, UT.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, North Dakota, Utah.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these packs immediately?
The recall does not require immediate stop use; affected packs should be checked for model and lot numbers to determine if they are at risk.
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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-0939-2026 (November 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0939-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.