Device recall

Z-2055-2015: Lombart 90D Clear with case Visualization during diagnosis and laser therapy of…

FDA device recall · Class III · Volk Optical Inc

Key facts

Recall number (Z-number) Z-2055-2015
Recall event 71048
Product Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
Product code HJI
Recalling firm Volk Optical Inc
Recall class Class III
Status Terminated
Termination date Feb 4, 2016
FEI number 1000122772

At a glance

  • None 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)