Alcon recalls accessory devices for Unity and Constellation surgical consoles due to incomplete pouch seals that may compromise sterile barrier during surgery.
Due to incomplete seals in the pouch which provide the sterile barrier.
Alcon is recalling accessory devices for Unity and Constellation surgical consoles because their pouches have incomplete seals that could break the sterile barrier during surgery. This risk affects surgeons and surgical teams using these devices.
The pouches that provide sterile barriers for these surgical devices have incomplete seals. This could allow contamination to enter the device during surgery, potentially leading to infections or complications.
Surgeons and surgical teams using Alcon Unity and Constellation surgical consoles with the affected accessory devices. The risk is primarily for medical professionals during vitrectomy procedures.
Check for model numbers: 8065000250 (UNITY 27+DS HYPERVIT 30K VIT PROBE), 8065753168 (UNITY 25+ 7.5K ANTERIOR VIT PROBE), or 8065753179 (UNITY 25+ HYPERVIT 30K VIT PROBE). These devices were sold with specific lot/batch numbers listed in the recall notice.
Identify the model number on the device to see if it matches the affected list: 8065000250, 8065753168, or 8065753179.
The pouches that provide sterile barriers for these surgical devices have incomplete seals, which could allow contamination during surgery.
No, the recall does not require immediate discontinuation. The hazard is low risk and does not pose a serious injury risk in normal use.
Check the model number to see if it is on the affected list. If it is, contact Alcon for further instructions.
We’ve drafted a message you can send Alcon to request your refund or repair — edit it as you like.
Subject: Recall Z-0304-2026 — Alcon Alcon Hello, I own a Alcon that is covered by recall Z-0304-2026 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.
