Alcon Research, LLC Constellation Vision System, REF: 8065751150 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Constellation Vision System, REF: 8065751150
Brand
Alcon Research, LLC
Lot Codes / Batch Numbers
UDI-DI: 00380657511501, Serial Numbers: 1403028701X, 1202865201X, 0802983301X
Products Sold
UDI-DI: 00380657511501, Serial Numbers: 1403028701X, 1202865201X, 0802983301X
Alcon Research, LLC is recalling Constellation Vision System, REF: 8065751150 due to Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
GA, IL, PR
Page updated: Jan 10, 2026