Alcon recalls Constellation Procedure Pak with catalog numbers 8065750958 and product code 100007216 due to potential plastic debris from over-tightening with included wrench, risking 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 Constellation Procedure Pak devices that may cause plastic debris when over-tightened with the included plastic wrench during medical procedures. This could lead to patient injury if the debris enters the surgical site.
Over-tightening the procedure pak with the plastic wrench can cause plastic debris to break off. This debris may enter the surgical site during procedures, potentially causing injury to patients.
Medical professionals using the Constellation Procedure Pak for surgical procedures are most at risk, particularly when tightening components with the included plastic wrench.
Check for catalog number 8065750958 or product code 100007216 on the device. The recall includes specific lot numbers such as 14XM2J, 14Y1H6, and others listed in the record.
Look for catalog number 8065750958 or product code 100007216 on the device, and check the lot numbers listed in the recall.
Over-tightening the procedure pak with the included plastic wrench can cause plastic debris to break off, which may enter the surgical site and cause patient injury.
Check for catalog number 8065750958 or product code 100007216 on the device, and verify the lot numbers listed in the recall (e.g., 14XM2J, 14Y1H6).
The recall does not specify a remedy, so contact Alcon directly for guidance on next steps.
We’ve drafted a message you can send Alcon to request your refund or repair — edit it as you like.
Subject: Recall Z-2406-2023 — Alcon Alcon Hello, I own a Alcon that is covered by recall Z-2406-2023 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.
