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U.S. Department of Health and Human Services

Class 2 Device Recall Constellation Vision System Pneumatic Handpiece

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 Class 2 Recall
Constellation Vision System Pneumatic Handpiece
see related information
Date Posted June 06, 2013
Recall Status1 Open
Recall Number Z-1506-2013
Recall Event ID 65006
Product Classification Instrument, Vitreous Aspiration And Cutting, Ac-Powered - Product Code HQE
Product The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.
Code Information All Lots of the Constellation Vision System Pneumatic Handpiece, DSP, product number 725.01
Recalling Firm/
Manufacturer
Alcon Grieshaber AG
Winkelriedstrasse 52
Schaffhausen
For Additional Information Contact Alcon Representative
800-345-8139
Manufacturer 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 Determined
Cause 2
TRAINING: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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