Z-0099-2024Class II

Constellation Vision System, REF: 8065751150

Name: Z-0099-2024 Constellation Vision System, REF: 8065751150
Creator: Alcon Research, LLC
Published: 2023-08-18
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2023-08-18 / Open, Classified / root cause: design

FDA source

Alcon Research, LLC began a recall of Constellation Vision System, REF: 8065751150 on 2023-08-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0099-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-18
Posted: 2023-10-11
Recalling firm: Alcon Laboratories
Product: Constellation Vision System, REF: 8065751150
Product code: HQC Unit, Phacofragmentation
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.
Root cause tag: design
FDA root cause: Component change control
Action: 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.
Quantity in commerce: 3
Distribution: US: GA, IL, PR
Product codes and lots: UDI-DI: 00380657511501, Serial Numbers: 1403028701X, 1202865201X, 0802983301X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0099-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0099-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-11

Product code HQC

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)