Device recall

Z-0835-2025: Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog…

FDA device recall · Class II · Alcon Research LLC

Key facts

Recall number (Z-number) Z-0835-2025
Recall event 95903
Product Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch III D delivery cartridge Lens Guide, Intraocular Component: N/A
Product code KYB
Recalling firm Alcon Research LLC
Recall class Class II
Status Open, Classified
510(k) numbers K063155
FEI number 1610287

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)