Product: Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill needle, NDC 50242-078-55; and b) carton labeled as Susvimo Ocular Implant with Insertion Tool Assembly, containing One carrier with implant and One insertion Tool, UDI 81004259001, GTIN 00810042590014, Rx only, Genentech, Inc., A Member of the Roche Group, South San Francisco, CA  94080-4990.
Reason for recall: Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.
Recall initiated: 20221018
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated