Z-2081-2016Class II

CENTURION Vision System

Name: Z-2081-2016 CENTURION Vision System
Creator: Alcon Research, Ltd.
Published: 2016-05-24
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2016-05-24 / Terminated / root cause: manufacturing process

FDA source

Alcon Research, Ltd. began a recall of CENTURION Vision System on 2016-05-24. FDA classified it as Class II and gives the reason as "The grounding pin within the Power Entry Switch on certain systems was susceptible to detachment when the AC power cable is removed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2081-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-24
Posted: 2016-06-28
Terminated: 2017-04-13
Recalling firm: Alcon Laboratories
Product: CENTURION Vision System
Product code: HQC Unit, Phacofragmentation
Reason for recall: The grounding pin within the Power Entry Switch on certain systems was susceptible to detachment when the AC power cable is removed.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Alcon has already notified the affected customer verbally on May 24, 2016, and via written correspondence on June 1, 2016. The device was corrected on May 26, 2016, and the Power Entry Switch that was removed from the customers CENTURION Vision System did not exhibit a grounding pin susceptible to detachment. For further questions, please call (817) 293-0450.
Quantity in commerce: 1 unit
Distribution: US Distribution to Illinois
Product codes and lots: Serial Number 1601444801X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2081-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2081-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-28

Product code HQC

K121555Class IICenturion Vision SystemAlcon Laboratories, Inc. / cleared 2012-12-21

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)