CustomEyes kits
- Recall Initiated
- December 20, 2022
- Posted
- March 1, 2023
- Recall Number
- Z-1200-2023
- Quantity
- 4640 units in total
- Firm Location
- City Point Waltham, MA
Reason for Recall
Device packaging may contain open seals, compromising product sterility.
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
Lot / Code Info
Catalog #BVI-58001086 and BVI-58001089, Lot Numbers 6051841, 6052299, 6051842, 6052300 UDI/DI: 50886158021990 and 50886158021969
Root Cause
Process control
Action Taken
A consignee letter was issued to impacted customers on January 18, 2023. The communication advises consignees to immediately examine inventory and quarantine product from impacted lots. If further distribution has occurred, a sub-recall should be initiated. A completed copy of the Business Response Form shall be completed and returned to beavervisitec8978@sedgwick.com.