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Recall Observatory FDA recall evidence

Device product

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

Z-1506-2013

April 17, 2013

Class II

Product summary

Firm
Alcon Grieshaber AG
Event
Event 65006
Status
Terminated
Classification
Class II
Quantity
8,455 units
Official record key
device-enforcement:Z-1506-2013

Official wording

Reason: 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.

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.