Constellation Vision System — Class II medical device recall Z-0099-2024
Ongoing recall by Alcon Research, LLC, reported 2023-10-18, distributed in GA, IL, PR. Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to highe
| Recall number | Z-0099-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, LLC, Irvine, CA, United States |
| Recall initiated | 2023-08-18 |
| Classified | 2023-10-11 |
| Reported by FDA | 2023-10-18 |
| Distributed | GA, IL, PR |
| Quantity | 3 |
| Reason classes | microbial contamination |
| UPC / GTIN / UDI-DI | 00380657511501 |
| Serial numbers | 0802983301X, 1202865201X, 1403028701X |
| Model numbers | 8065751150 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0099-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.