Constellation Vision System, REF: 8065751150
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.
US: GA, IL, PR
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0099-2024