Recall Z-0099-2024 ยท HQC Unit, Phacofragmentation
Alcon Research, LLC
Constellation Vision System, REF: 8065751150
| Date | Oct 11, 2023 (initiated Aug 18, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Component change control |
| Action | 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. |
| Quantity | 3 |
| Distribution | US: GA, IL, PR |
| FDA record | Open on fda.gov |