Device recall

Z-2802-2011: iSert Intraocular Lens (Model PC-60AD)

FDA device recall · Class II · Hoya Surgical Optics, Inc.

Key facts

Recall number (Z-number) Z-2802-2011
Recall event 59207
Product iSert Intraocular Lens (Model PC-60AD)
Product code HQL
Recalling firm Hoya Surgical Optics, Inc.
Recall class Class II
Status Terminated
Termination date Nov 29, 2012
FEI number 3006723646

At a glance

  • None 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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