FDA Device recall Z-0099-2024
Constellation Vision System, REF: 8065751150
- FDA Device
- Class II
- ongoing
- Published 2023-10-18
On 2023-10-18 the FDA classified a Class II recall of Constellation Vision System, REF: 8065751150 by Alcon Research, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0099-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-18 |
| Published | 2023-10-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Alcon Research |
| Distribution | GA, IL, PR |
Product
Constellation Vision System, REF: 8065751150
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.
Identifiers
| code_info | UDI-DI: 00380657511501, Serial Numbers: 1403028701X, 1202865201X, 0802983301X |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0099-2024%22
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