Home / Recalls / Alcon Grieshaber AG / Z-1506-2013

Z-1506-2013 Class II Terminated

Recalled by Alcon Grieshaber AG — Schaffhausen, N/A

FDA device recall Z-1506-2013 was initiated by Alcon Grieshaber AG on April 17, 2013 and is designated Class II. 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) m… The recall status is terminated (terminated January 7, 2015). Affected quantity: 8,455 units.

Recall Details

Product Type: Devices
Report Date: June 12, 2013
Initiation Date: April 17, 2013
Termination Date: January 7, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8,455 units

Product Description

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

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.

Distribution Pattern

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.

Code Information

All Lots of the Constellation Vision System Pneumatic Handpiece, DSP, product number 725.01