Constellation Vision System recall: Contamination
Constellation Vision System, REF: 8065751150
Why was Constellation Vision System recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00380657511501, Serial Numbers: 1403028701X, 1202865201X, 0802983301X
- Product
- Constellation Vision System, REF: 8065751150
- Recalling firm
- Alcon Research, LLC
- Quantity
- 3
- Distribution
- US: GA, IL, PR
- Recall date
- October 18, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)