FDAFDA · Food and drugs·Recall number Z-1506-2013
The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.
Published June 12, 2013 · Recall initiated: April 17, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Alcon Grieshaber AG
- Distributor
- 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.
- Lot
- All Lots of the Constellation Vision System Pneumatic Handpiece, DSP, product number 725.01
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
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