Alcon Research LLC
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Due to incomplete seals in the pouch which provide the sterile barrier.
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
Catalog Number: 8065000356 UDI-DI code: 00380650003560 Lot/Batch Numbers: 17CFND Catalog Number: 8065000358 UDI-DI code: 00380650003584 Lot/Batch Numbers: 17CMKW 17DR9L Catalog Number: 8065000359 UDI-DI code: 00380650003591 Lot/Batch Number: 17DWCY Catalog Number: 8065000467 UDI-DI code: 00380650004673 Lot/Batch Number: 17CP3T Catalog Number: 8065000468 UDI-DI code: 00380650004680 Lot/Batch Number: 17CP3U
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →