PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: November 24, 2021 Initiated: October 8, 2021 #Z-0230-2022

Product Description

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

Details

Units Affected
2 units
Distribution
Nationwide Foreign: Australia Austria France Germany Netherlands Spain Japan Russia South Africa UK
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
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. Recalled by Beaver Visitec International, Inc.. Units affected: 2 units.
Why was this product recalled?
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
Which agency issued this recall?
This recall was issued by the FDA Devices on November 24, 2021. Severity: Moderate. Recall number: Z-0230-2022.