Device recall

Z-0468-2024: EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.

FDA device recall · Class II · Staar Surgical Company

Key facts

Recall number (Z-number) Z-0468-2024
Recall event 93312
Product EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
Product code MTA
Recalling firm Staar Surgical Company
Recall class Class II
Status Open, Classified
PMA numbers P030016
FEI number 2023826

At a glance

  • None Linked 510(k)s
  • 10–99 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)