Catalys Precision Laser System 의 리콜

Recall

RC-2015-RN-00240-1

Class II

2015-03-19

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00240-1

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 treatmenta 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 theacceptable range, the system will stop the laser from activating during treatment and displays a message.2. auto-population of cataract incision templatea 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 incisionsurgeon templates.

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.