| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00424-1 |
| Product Name/Description |
LenSx Laser System (used for femtosecond cataract surgery)
Serial numbers: 0611-A020, 0711-A022, 1011-A053, 1011-A060, 0312-A123
ARTG Number: 181017 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
Alcon is addressing reports of unexpected downward motion of the gantry. These reports are associated with systems manufactured with an older style motor/brake assembly. A new style motor/brake assembly (current version) has been used in manufacturing since May 2012. Of the 41 reports, contact with the patient's eye or face was reported in three instances. In all of these cases, the contact with patient eye resulting from the unexpected downward gantry motion did not lead to a serious injury or a serious deterioration in state of health. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
If customers experience any unexpected gantry movement, they are advised to immediately notify Alcon and stop using the LenSx Laser System. Alcon will replace and install the current motor/brake assembly on any impacted LenSx Laser System manufactured prior to May 2012, including those that have not been previously upgraded. |
| Contact Information |
02 9452 9387 - Alcon Laboratories Regulatory Affairs |