FDA Device

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

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 You Should Do

Remedy

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.

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Products

The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.
Brand
Alcon Grieshaber AG Winkelriedstrasse 52 Schaffhausen Switzerland
UPC
All Lots of the Constellation Vision System Pneumatic Handpiece, DSP, product number 725.01

Units Affected

8,455 units

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