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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Event Detail

Event ID 65006
Product Type Devices
Status Ongoing
Recalling Firm Alcon Grieshaber AG
City Schaffhausen
Country CH
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-17
Initial Firm Notification of
Consignee or Public
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, Turknenistan, Venezula, and Viet Nam.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery. All Lots of the Constellation Vision System Pneumatic Handpiece, DSP, product number 725.01 Class II 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. 8,455 units Z-1506-2013