Constellation recallZ-0099-2024 · Alcon Research, LLC · initiated Aug 18, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Alcon Research, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Component change control
What the company is doing
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 [email protected] Should you have any questions or concerns call Customer Service at 1-800-862-5266.
Recall details
- Recall number
- Z-0099-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 18, 2023
- Posted by the FDA
- Oct 11, 2023
- Recalling firm
- Alcon Research, LLC
- Quantity
- 3
- Product code
- HQC
- FDA submissions
- K141065, K101285
- Distribution
- US: GA, IL, PR
Product description
Constellation Vision System, REF: 8065751150
Code information (models, lots, serial numbers)
UDI-DI: 00380657511501, Serial Numbers: 1403028701X, 1202865201X, 0802983301X
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CONSTELLATION 8065751150Alcon Laboratories, Inc. · Instrument, vitreous aspiration and cutting, ac-powered1 recall1,246 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page