Alcon Research, LLC: Medical Device Recall in 2023 - (Recall #: Z-0099-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Constellation Vision System, REF: 8065751150

Product Classification:

Class II

Date Initiated: August 18, 2023

Date Posted: October 18, 2023

Recall Number: Z-0099-2024

Event ID: 93010

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.

Status: Ongoing

Product Quantity: 3

Code Information:

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

Distribution Pattern:

US: GA, IL, PR

Voluntary or Mandated:

Voluntary: Firm initiated