Z-1506-2013Class II

The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment...

Name: Z-1506-2013 The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment...
Creator: Alcon Grieshaber AG
Published: 2013-04-17
License: https://open.fda.gov/license/

Alcon Grieshaber AG / initiated 2013-04-17 / Terminated

FDA source

Alcon Grieshaber AG began a recall of The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery on 2013-04-17. FDA classified it as Class II and gives the reason as "Alcon is conducting a Medical Device Removal for the Constellation Pneumatic Handpiece, DSP, product number 725.01. This action is being taken because the forceps or scissors tips (sold separately) may dislodge from the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1506-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-17
Posted: 2013-06-06
Terminated: 2015-01-07
Recalling firm: Alcon Grieshaber AG
Product: The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.
Product code: HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Reason for recall: Alcon is conducting a Medical Device Removal for the Constellation Pneumatic Handpiece, DSP, product number 725.01. This action is being taken because the forceps or scissors tips (sold separately) may dislodge from the hand piece, if not attached by the user according to the Directions for Use.
FDA root cause: Use error
Action: Alcon sent an "URGENT: MEDICAL DEVICE REMOVAL" letter on April 17, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local Alcon Sales Representative for questions regarding this notice.
Quantity in commerce: 8,455 units
Distribution: Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Canada, Chile, China, Egypt, France, Germany, Great Britain, India, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Kyrgyzstan, Lebanon, Korea, Malaysia, Mexico, Pakistan, Peru, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Turkistan, Venezuela, and Veit Nam.
Product codes and lots: All Lots of the Constellation Vision System Pneumatic Handpiece, DSP, product number 725.01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1506-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1506-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06

Product code HQE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)