| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00522-1 |
| Product Name/Description |
LenSx Laser System with Corneal Flap Capability (used to perform corneal flaps in LASIK surgery or other treatment involving the incision of the cornea)
Catalogue Number: 8065998162
ARTG Number: 181017 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
Alcon is conducting a Recall for Product correction of all LenSx Laser Systems with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which manifests as un-dissected area(s) within the side cut. If an un-dissected area in the side cut is observed, it may cause difficulty lifting the flap, potentially resulting in corneal tear, irregular stromal bed, or a corneal epithelial defect. This issue has been confirmed to manifest in only a small number of systems through the normal installation setup and optimisation process. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Alcon is advising users that the LenSx system can continue to be used, and to exercise professional medical judgement when determining the management of potential side cut issues. Alcon will be implementing a software upgrade in order to minimise any incomplete areas within the side cut. This action has been closed-out on 03/02/2017. |
| Contact Information |
02 9452 9274 - Alcon Laboratories |