Alcon recalls specific lots of Constellation Vision System Vitrectomy Procedure Paks due to potential sterility compromise from manufacturing damage. Affected units include various model numbers and lot codes listed in Attachment 1.
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 Vitrectomy Procedure Paks because some units may have been damaged during manufacturing, risking sterility. This could lead to infections if used in surgery without proper sterility.
The recall is due to potential damage during manufacturing that affects the lidding area. This damage could compromise sterility, meaning the surgical pack might not be sterile when used, increasing infection risk during eye surgery.
Surgical teams using the Constellation Vision System Vitrectomy Procedure Paks for eye surgery are most at risk if they use affected lots. Patients and surgeons should check the lot numbers listed in the official recall notice.
Check the lot numbers listed in Attachment 1 (e.g., 177FE4, 1782JM) for the specific affected products. The product includes model numbers like 8065000093 or 8065752435.
Review the lot numbers listed in Attachment 1 to determine if your product is affected.
Some units within specific lots were damaged during manufacturing, which could compromise sterility.
Check the lot numbers listed in Attachment 1 (e.g., 177FE4, 1782JM) for the specific affected products.
The recall does not specify a remedy, so affected products should be checked against the list and handled with caution.
We’ve drafted a message you can send Alcon to request your refund or repair — edit it as you like.
Subject: Recall Z-2108-2025 — Alcon Alcon Hello, I own a Alcon that is covered by recall Z-2108-2025 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.
