Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000359 27GA
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | August 05, 2025 |
| Reported | November 05, 2025 |
| Recalling firm | Alcon Research LLC |
| Country / region | United States TX |
Hazard
Due to incomplete seals in the pouch which provide the sterile barrier.
Product description
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000359 27GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000467 25GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD 8065000468 27GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Affected products
- Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachmen
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