Device recall

Z-1340-2012: RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software)

FDA device recall · Class II · Optovue Inc.

Key facts

Recall number (Z-number) Z-1340-2012
Recall event 61373
Product RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software)
Product code OBO
Recalling firm Optovue Inc.
Recall class Class II
Status Terminated
Termination date Apr 2, 2012
510(k) numbers K111505
FEI number 3005950902

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

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