Device product
CustomEyes kits
Z-1200-2023
Product summary
- Event
- Event 91488
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4640 units in total
- Official record key
device-enforcement:Z-1200-2023
Official wording
Reason: Device packaging may contain open seals, compromising product sterility.
Code information: Catalog #BVI-58001086 and BVI-58001089, Lot Numbers 6051841, 6052299, 6051842, 6052300 UDI/DI: 50886158021990 and 50886158021969
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
Derived failure modes
-
Sterility assurance
packaging may contain open seals, compromising product sterility