Recall MonitorHealth Products
Constellation® Vision System Total Plus Vitrectomy Pak
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Ophthalmology
Product: Constellation® Vision System Total Plus Vitrectomy Pak
Issue: Medical devices - Labelling and packaging
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Constellation® Vision System Total Plus Vitrectomy Pak | More than 10 numbers, contact manufacturer. | 8065000093 |
| Constellation® Vision System Total Plus Vitrectomy Pak | More than 10 numbers, contact manufacturer. | 8065752437 |
| Constellation® Vision System Total Plus Vitrectomy Pak | More than 10 numbers, contact manufacturer. | 8065753109 |
| Constellation® Vision System Total Plus Vitrectomy Pak | More than 10 numbers, contact manufacturer. | 8065752435 |
| Constellation® Vision System Total Plus Vitrectomy Pak | More than 10 numbers, contact manufacturer. | 8065753106 |
Issue
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