Official recall record

Alcon Vitrectomy Products

What the authority reported

Alcon is conducting this voluntary medical device field safety correction of impacted standalone vitrectomy consumables, as there is potential for some pouches within impacted lots to have an incomplete seal. While the incomplete seal is visibly noticeable within the pouch, due to the risk that the sterile barrier may be compromised, Alcon is conducting a recall. Should a non-sterile product be used during surgery, post-operative infection may result requiring medical and/or surgical intervention. To date, there have been no reported complaints for this issue from customers for the product in scope. Recall start date: August 11, 2025

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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