Alcon recalls specific lots of Constellation Vision System surgical procedure packs due to potential sterility compromise from manufacturing damage to lidding. Affected units may not be safe for surgery.
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.
Alcon is recalling certain lots of Constellation Vision System surgical procedure packs because some units had damage during manufacturing that could compromise sterility. This means the packs might not be safe for surgical use if they are damaged.
The lidding (the protective cover) on some units was damaged during manufacturing. This damage could allow contamination, making the surgical packs unsafe for procedures if they are not properly sterilized.
Surgical teams using Alcon Constellation Vision System procedure packs with specific lot numbers listed in the recall notice. The risk is low as the damage is visible and only affects sterility, not causing immediate injury.
Check the lot numbers listed in the recall notice (e.g., 1762K1, 176WTW) on the product packaging. The affected packs have specific catalog numbers and UDI-DI codes as detailed in the attached list.
Look for lot numbers like 1762K1 or 176WTW on the packaging to determine if your unit is affected.
Alcon recalls specific lots of Constellation Vision System surgical packs because manufacturing damage to the lidding could compromise sterility, making them unsafe for surgery.
Check the lot numbers listed in the recall notice (e.g., 1762K1, 176WTW) on the product packaging. Affected units have specific catalog numbers and UDI-DI codes as detailed in the attached list.
The recall notice 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-2109-2025 — Alcon Alcon Hello, I own a Alcon that is covered by recall Z-2109-2025 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.
