Home / Recalls / Alcon Research, LLC / Z-0099-2024

Z-0099-2024 Class II Ongoing

Recalled by Alcon Research, LLC — Irvine, CA

Recall Details

Product Type
Devices
Report Date
October 18, 2023
Initiation Date
August 18, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3

Product Description

Constellation Vision System, REF: 8065751150

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 Pattern

US: GA, IL, PR

Code Information

UDI-DI: 00380657511501, Serial Numbers: 1403028701X, 1202865201X, 0802983301X

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  • Z-2110-2025 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Nu (April 28, 2025)
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