Device recall

Z-1947-2014: Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number…

FDA device recall · Class II · Alcon Research, Ltd.

Key facts

Recall number (Z-number) Z-1947-2014
Recall event 68335
Product Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space…
Product code LRO
Recalling firm Alcon Research, Ltd.
Recall class Class II
Status Terminated
Termination date Dec 9, 2014
510(k) numbers K880961
FEI number 1610287

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1,000+ 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)