Alcon recalls Custom Pak devices with specific catalog numbers due to potential plastic debris from over-tightening with included wrench. Patients may experience injury during procedures. Check your product's catalog number to see if it's affected.
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Alcon is recalling Custom Pak devices that may shed plastic debris when over-tightened with the included plastic wrench, potentially causing injury during procedures. Affected units have specific catalog numbers listed in the recall.
Over-tightening the Custom Pak with the included plastic wrench can cause plastic debris to break off, which may then cause injury during medical procedures.
Patients using the Custom Pak during procedures are most at risk. The recall applies to specific catalog numbers listed in the notice.
Check your Custom Pak's catalog number against the list of affected numbers provided in the recall notice. The affected units have specific catalog numbers starting with a range of codes.
Look for the catalog number on your Custom Pak device to see if it's in the list of affected numbers.
Over-tightening the Custom Pak with the included plastic wrench can cause plastic debris to break off, potentially leading to injury during procedures.
Check your Custom Pak's catalog number against the list of affected numbers provided in the recall notice.
No, but you should check your catalog number to see if it's affected. If it is, follow the action steps to ensure safety.
We’ve drafted a message you can send Alcon to request your refund or repair — edit it as you like.
Subject: Recall Z-2411-2023 — Alcon Alcon Hello, I own a Alcon that is covered by recall Z-2411-2023 from Alcon. 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.
