Skip to content
Recall Observatory FDA recall evidence

Device product

bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sample for evaluation purposes REF# BVI 58000587

Z-0230-2022

October 08, 2021

Class II

Product summary

Firm
Beaver Visitec International, Inc.
Event
Event 88826
Status
Ongoing
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-0230-2022

Official wording

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

Code information: Lot Number 6018382

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