FDA recall Z-0230-2022

Beaver Visitec International, Inc. · Class II · 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

Reason for recall

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

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2021-10-08
Report date: 2021-11-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0230-2022