Device recall

Z-1670-2013: Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The…

FDA device recall · Class II · Abbott Medical Optics, Inc.

Key facts

Recall number (Z-number) Z-1670-2013
Recall event 65292
Product Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Product code HQC
Recalling firm Abbott Medical Optics, Inc.
Recall class Class II
Status Terminated
Termination date Oct 6, 2014
510(k) numbers K111446
FEI number 3006695864

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)