Alcon recalls Centurion FMS Pak devices with catalog numbers 8065000133-8065753159 due to potential plastic debris from over-tightening with included wrench, reported to cause patient injury during procedures.
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Alcon is recalling Centurion FMS Pak devices that may shed plastic debris if over-tightened with the included plastic wrench, which has been reported to cause patient injuries during medical procedures. This is a safety issue that requires careful handling to prevent harm.
Over-tightening the Centurion FMS Pak with the included plastic wrench can cause plastic debris to break off, which has been reported to injure patients during medical procedures. This risk occurs when the device is tightened beyond the recommended torque.
Medical professionals using the Centurion FMS Pak devices for procedures are most at risk, particularly those who may over-tighten the device with the included plastic wrench.
Check for catalog numbers 8065000133 through 8065753159 or product codes 100241014 through 100208838 in the device's label or packaging. Also look for UDI-DI codes starting with 380650001337 through 380657531592.
Look for catalog numbers 8065000133-8065753159 or product codes 100241014-100208838 on the device label or packaging.
Ensure you are using the correct wrench for the device to avoid over-tightening, which can cause plastic debris to shed.
Over-tightening the device with the included plastic wrench can cause plastic debris to break off, which has been reported to injure patients during medical procedures.
Check for catalog numbers 8065000133 through 8065753159 or product codes 100241014 through 100208838 on the device label or packaging.
No, but you should be careful not to over-tighten the device with the included wrench, as this can cause plastic debris to shed and injure patients.
We’ve drafted a message you can send Alcon Research to request your refund or repair — edit it as you like.
Subject: Recall Z-2407-2023 — Alcon Research Alcon Research Hello, I own a Alcon Research that is covered by recall Z-2407-2023 from Alcon Research. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
