medical Class II Updated 2023-10-18

Alcon Research, LLC recalls Constellation Vision System, REF: 8065751150

Recalled Product

Constellation Vision System, REF: 8065751150


Hazard / Issue

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.

Issued by

FDA

Affected States: GA, IL
Lot/Code Info: UDI-DI: 00380657511501, Serial Numbers: 1403028701X, 1202865201X, 0802983301X
View official government recall

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