Official recall record

Constellation® Vision System Total Plus Vitrectomy Pak

Health Canada — Medical Devices · 2025-07-30 · CanadaType II

Issuing authority: Health Canada — Medical Devices
Published: 2025-07-30
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

On May 1, 2025 Alcon Canada was notified of market action due to damaged Tyvek® covers on specific lots of Alcon Constellation Pak®. Due to the risk of Constellation Pak® sterility being compromised, Alcon is correcting potentially affected lots. There is the potential that the Tyvek® cover of some units within specific lots of Alcon Constellation Pak® were damaged during the manufacturing process. This event was identified internally by Alcon. To date, no customer complaints or adverse events reported. Recall start date: May 6, 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.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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