Z-0099-2024 Class II Ongoing
FDA device recall Z-0099-2024 was initiated by Alcon Research, LLC on August 18, 2023 and is designated Class II. 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 cont… The recall status is ongoing. Affected quantity: 3.
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