Alcon recalls Custom Paks with specific lot numbers due to potential sterility compromise from manufacturing damage. Affected units may not be sterile, risking infection during surgery.
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.
Alcon is recalling certain Custom Paks surgical kits because some units had damage during manufacturing that could compromise sterility. This means the kits might not be sterile when used, increasing infection risk during eye surgery.
The damage occurs in the lidding area during manufacturing, which could compromise sterility. While visibly noticeable, this damage might lead to non-sterile kits that could cause infection during surgery.
Ophthalmic surgeons who use Alcon Custom Paks for eye surgery are most at risk, particularly those who have the affected lot numbers listed in the recall notice.
Check the lot code or catalog number on the Custom Pak packaging. Affected units are listed in Attachment 1 - Affected Product List, which includes specific lot codes and catalog numbers.
Review the Attachment 1 - Affected Product List for your specific lot code or catalog number to confirm if your Custom Pak is affected.
Due to potential damage during manufacturing that could compromise sterility in the lidding area of some Custom Paks.
Check the lot code or catalog number on the packaging against the list in Attachment 1 - Affected Product List.
No action is needed if your Custom Pak is not listed in Attachment 1 - Affected Product List.
We’ve drafted a message you can send Alcon Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-2110-2025 — Alcon Laboratories Alcon Laboratories Hello, I own a Alcon Laboratories that is covered by recall Z-2110-2025 from Alcon Laboratories. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
