FDA-Device2023-10-18Class II
Constellation Vision System, REF: 8065751150
Alcon Research, LLC
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.
Sold states
US: GA, IL, PR
Affected count
3
Manufactured in
15800 Alton Pkwy, N/A, Irvine, CA, United States
Products
Constellation Vision System, REF: 8065751150
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0099-2024Don't want to check this manually?
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