FDAAugust 18, 2023device

Constellation Vision System, REF: 8065751150

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

alcon researchalcon

UPCs

00380657511501

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Constellation Vision System, REF: 8065751150 — Recall Details · AllClear