Skip to content
Recall Observatory FDA recall evidence

Device product

bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar¿ Crescent Knife (REF#373809) as a component a) REF# 588221 REF#: 373809

Z-0228-2022

October 08, 2021

Class II

Product summary

Firm
Beaver Visitec International, Inc.
Event
Event 88826
Status
Ongoing
Classification
Class II
Quantity
500 eaches
Official record key
device-enforcement:Z-0228-2022

Official wording

Reason: Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades

Code information: Lot Numbers 3296729, 3299124, 3305081, 3307565, 3312464, 3324620, 6033588. UDI: " Primary: 00886158112839 " Secondary: 30886158112830 " Tertiary: 50886158112834

Distribution pattern: Nationwide Foreign: Australia Austria France Germany Netherlands Spain Japan Russia South Africa UK

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades