Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure control for the use of cutters, scissors, and forceps, which could lead to an increased risk of microbial infection, tissue damage and progressive visual impairment.
Reason for recall: Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure control for the use of cutters, scissors, and forceps, which could lead to an increased risk of microbial infection, tissue damage and progressive visual impairment. Distribution: US: GA, IL, PR Quantity: 3 Lot/code info: UDI-DI: 00380657511501, Serial Numbers: 1403028701X, 1202865201X, 0802983301X
00380657511501
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.