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Recall Observatory FDA recall evidence

Device product

bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component REF# 58000572 REF#: 373809

Z-0229-2022

October 08, 2021

Class II

Product summary

Firm
Beaver Visitec International, Inc.
Event
Event 88826
Status
Ongoing
Classification
Class II
Quantity
125 eaches
Official record key
device-enforcement:Z-0229-2022

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 6032947 and 6033588 UDI: " Primary: 00886158019961 " Secondary: 30886158019962 " Tertiary: 50886158019966

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