Recall Z-0228-2022— Beaver Visitec International, Inc.

Name: FDA recall Z-0228-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-08

Class II · Ongoing

Class II FDA medical device recall by Beaver Visitec International, Inc., initiated 2021-10-08. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades.

Recalling firm: Beaver Visitec International, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-10-08
Firm location: Waltham, MA, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.