CustomEyes kits
FDA Recall #Z-1200-2023 — Class II — December 20, 2022
Product Description
CustomEyes kits
Reason for Recall
Device packaging may contain open seals, compromising product sterility.
Recalling Firm
Beaver Visitec International, Inc. — Waltham, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
4640 units in total
Distribution
US distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI OUS distribution to Canada, Japan, and South Africa
Code Information
Catalog #BVI-58001086 and BVI-58001089, Lot Numbers 6051841, 6052299, 6051842, 6052300 UDI/DI: 50886158021990 and 50886158021969
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated