Z-1200-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 8, 2023
- Initiation Date
- December 20, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4640 units in total
Product Description
CustomEyes kits
Reason for Recall
Device packaging may contain open seals, compromising product sterility.
Distribution Pattern
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