Alcon recalls accessory devices for Unity and Constellation surgical consoles due to incomplete pouch seals that may compromise sterile barrier protection during vitrectomy procedures.
Due to incomplete seals in the pouch which provide the sterile barrier.
Alcon is recalling accessory devices for Unity and Constellation surgical consoles because the pouches that maintain sterile barriers have incomplete seals. This could allow contamination during delicate eye surgery procedures.
The pouches that provide sterile barriers for surgical instruments have incomplete seals. This could allow contaminants to enter the sterile field during eye surgery, potentially causing infection or complications.
Surgical teams using Alcon Unity and Constellation surgical consoles with the affected accessory devices. The risk is primarily for medical professionals performing vitrectomy procedures.
Check for model numbers 8065000356, 8065000358, 8065000359, 8065000467, or 8065000468 on the packaging. These devices were sold with specific batch numbers like 17CFND, 17CMKW, 17DR9L, 17DWCY, or 17CP3T/17CP3U.
Verify the model number on the packaging to see if it matches the affected list: 8065000356, 8065000358, 8065000359, 8065000467, or 8065000468.
Reach out to Alcon Research LLC for guidance on next steps if you have the affected devices.
The pouches that provide sterile barriers have incomplete seals, which could allow contaminants to enter during eye surgery.
The affected devices are for Alcon Unity and Constellation surgical consoles.
Check the model number on the packaging: 8065000356, 8065000358, 8065000359, 8065000467, or 8065000468. Also check batch numbers like 17CFND, 17CMKW, 17DR9L, 17DWCY, or 17CP3T/17CP3U.
We’ve drafted a message you can send Alcon to request your refund or repair — edit it as you like.
Subject: Recall Z-0308-2026 — Alcon Alcon Hello, I own a Alcon that is covered by recall Z-0308-2026 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.
