The Recall Desk

FDA (Devices) recall action 96832

Alcon Research LLC recalled 3 products on 2025-07-16

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2025-07-16
Critical
0
Units
303,257

Why these products were recalled

Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2025-07-16

    Alcon Constellation procedure packs may have damaged lidding compromising sterility

    Alcon Constellation Vision System Combined Procedure Paks are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 89,495 units affected.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellati
    Category
    Distribution
    50 states
  • HighFDA (Devices)··2025-07-16

    Alcon Custom Pak surgical kits may have damaged lidding compromising sterility

    Alcon Custom Paks, customer-designed sterile surgical kits, are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 15,557 kits affected.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intende
    Category
    Distribution
    50 states
  • HighFDA (Devices)··2025-07-16

    Alcon Constellation vitrectomy packs may have damaged lidding compromising sterility

    Alcon Constellation Vision System Vitrectomy Procedure Paks are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 198,205 units affected.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constella
    Category
    Distribution
    50 states