Recall Z-1506-2013 ยท HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Alcon Grieshaber AG
The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.
| Date | Jun 6, 2013 (initiated Apr 17, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Use error |
| Action | 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. |
| Quantity | 8,455 units |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.