| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01184-1 |
| Product Name/Description |
Alcon INFINITI Ultrasound PAKs - INFINITI Microsmooth Tapered Kelman 30°
(Ophthalmic Surgical Procedure Kit used with INFINITI Vision System)
Catalogue Number: 8065750280
Lot Number: 1628714H
ARTG number: 141454 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
Alcon received complaints for the INFINITI Ultrasound PAKs related to occlusion of the aspiration line. The investigation identified equipment misalignment during manufacturing which may have potentially detached a piece of the aspiration tubing and inserted it into the aspiration line of the INFINITI Ultrasound PAKs. Alcon is conducting this medical device recall due to the fact that the possibility exists for a loss of aspiration flow and / or occlusions of the aspiration line during surgery which may pose a safety risk to patients. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Alcon is requesting the users to immediately stop further use and segregate the affected lots of INFINITI Ultrasound PAKs. Replacement stock will be issued for units that are returned to Alcon. This action has been closed-out on 18/03/2016. |
| Contact Information |
02 9452 9387 - Alcon Laboratories Regulatory Affairs |