Recall archive / FDA device enforcement
Constellation Vision System, REF: 8065751150 — FDA record Z-0099-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 18, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Alcon Research, LLC
- Quantity
- 3
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0099-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00380657511501, Serial Numbers: 1403028701X, 1202865201X, 0802983301X |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: GA, IL, PR
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Oct 18, 2023
- Recall initiation date
- Aug 18, 2023
- Center classification date
- Oct 11, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.