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Alcon Grieshaber AG recalls The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surg
Recalled June 12, 2013 · FDA recall Z-1506-2013 · Alcon Grieshaber AG
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. · FDA Class II
Units
8,455 units
Sold at
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.
Description
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.
Product
The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.
Manufacturer(s)
Alcon Grieshaber AG
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →