Constellation Vision System, REF: 8065751150
This recall is currently active, issued October 11, 2023. It was issued by Alcon Research, Llc.
- Company
- Alcon Research, Llc
- Recall Initiated
- August 18, 2023
- Posted
- October 11, 2023
- Recall Number
- Z-0099-2024
- Quantity
- 3
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
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.
Distribution
US: GA, IL, PR
Lot / Code Info
UDI-DI: 00380657511501, Serial Numbers: 1403028701X, 1202865201X, 0802983301X
Root Cause
Component change control
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.