Constellation Vision System, REF: 8065751150
FDA device recall Z-0099-2024 · posted 2023-10-11 · Open, Classified
Recall details
- Recalling firm
- Alcon Research, LLC
- 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.
- Action taken
- Starting on 8/18/23, Field Service Engineers told customers their devices needed pneumatics module replacements, and this replacement activity was subsequently completed. On 9/29/23, correction notices were mailed to customers informing them vision systems were corrected and asking they complete and return the response form to Market.Actions@Alcon.com Should you have any questions or concerns call Customer Service at 1-800-862-5266.
- Root cause
- Component change control
- Status
- Open, Classified
- Product code
- HQC
- Quantity affected
- 3
- Distribution
- US: GA, IL, PR
- Date initiated
- 2023-08-18
- Date posted
- 2023-10-11
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONSTELLATION VISION SYSTEM (K141065) | Alcon Research, Ltd. | 2014-08-22 |
| CONSTELLATION VISION SYSTEM (K101285) | Alcon Manufacturing, Ltd. | 2010-11-12 |