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Recall Observatory FDA recall evidence

Device product

Constellation Vision System, REF: 8065751150

Z-0099-2024

August 18, 2023

Class II

Product summary

Firm
Alcon Research, LLC
Event
Event 93010
Status
Ongoing
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-0099-2024

Official wording

Reason: 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.

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

Distribution pattern: US: GA, IL, PR

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.