| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00240-1 |
| Product Name/Description |
Catalys Precision Laser System
Serial Numbers: 44056912, 44055711, 44072214, 44061512, 44057612
ARTG Number: 194204 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
Abbott Medical Optics is providing this notification to all customers who use the CATALYS System software version 3.00.05 to make you aware of two issues:
1. Loss of suction during treatment
A low probability event has been identified where loss of suction during treatment may result in scoring the cornea during lens fragmentation.
The CATALYS System has mitigations within its design to prevent this event from occurring, If the system detects a loss of vacuum or forces outside of the
acceptable range, the system will stop the laser from activating during treatment and displays a message.
2. Auto-population of cataract incision template
A low probability event has been identified for the cataract incision surgeon templates with software version 3.00.05, when selecting and deselecting an eye then selecting the other eye will result in the templates for both eyes having the same parameters. This event only affects the cataract incision
surgeon templates. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
AMO is advising that to prevent the incorrect auto-population of cataract incision templates end users must:
a) Verify the cataract incisions in the cataract incision a surgeon templates have the correct parameters, correct architecture and are in the desired location prior to saving.
b) Within the treatment planning phase and prior to activating the laser, verify all treatment incisions have the correct parameters, correct architecture and are in the desired location which are displayed on the screen.
This issue will be corrected in a software update.
AMO is also reinforcing the instructions for use with regard to suction loss. This action has been closed-out on 1/06/2016. |
| Contact Information |
1800 266 111 - AMO Australia |