Recall Z-1506-2013— Alcon Grieshaber AG
Class II · Terminated
Class II FDA medical device recall by Alcon Grieshaber AG, initiated 2013-04-17, terminated 2015-01-07. FDA's recall record names no specific 510(k) clearance for this event. Product: The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.. 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..
- Recalling firm
- Alcon Grieshaber AG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-17
- Terminated
- 2015-01-07
- Firm location
- Schaffhausen, N/A, Switzerland
Product description
The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.