| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00354-1 |
| Product Name/Description |
Constellation Pneumatic Handpiece, DSP (Ophthalmic surgical instrument handle)
Catalogue number: 725.01
All lot numbers affected
ARTG number: 196529 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
The forceps or scissors tips may dislodge from the handpiece, if not attached by the user according to the Directions for Use. |
| Recall Action |
Recall |
| Recall Action Instructions |
Alcon is asking customers to check their inventory and inform them, if there are any affected stock. An Alcon representative will be in contact to organise pick up of the affected handpieces. |
| Contact Information |
02 9452 9387 - Alcon Laboratories Regulatory Affairs |