Summary
The FDA issued a Class II for Constellation Vision System, REF: 8065751150 by Alcon Research, LLC. 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.
Details
Source
Device Recall
External ID
Z-0099-2024
Action Date
2023-10-18
Status
Ongoing
Category
device
Product Description
Constellation Vision System, REF: 8065751150
Lot/Code Info: UDI-DI: 00380657511501, Serial Numbers: 1403028701X, 1202865201X, 0802983301X
Quantity Affected: 3
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-18
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 179 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Alcon Research, LLC has 66 FDA actions in our database, including 66 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Alcon Research, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Alcon Research, LLC have FDA actions?
Alcon Research, LLC has 66 FDA actions in our database, including 66 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0099-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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