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Alcon Research, LLC recalls Constellation Vision System, REF: 8065751150
Recalled October 18, 2023 · FDA recall Z-0099-2024 · Alcon Research
Hazard
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. · FDA Class II
Units
3
Sold at
US: GA, IL, PR
Description
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.
Product
Constellation Vision System, REF: 8065751150
Manufacturer(s)
Alcon Research, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →