ACCURUS Vitrectomy probes 의 리콜

Recall

RC-2015-RN-00481-1

Class I

2015-06-05

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00481-1

Alcon has identified an insufficient seal on the outside packaging that could potentially affect the sterility of the product. the use of non-sterile vitrectomy probes in surgery has the potential to result in patient infection or inflammation and may lead to serious injury and sequelae, including loss of vision.. at this time, no adverse events or complaints have been confirmed related to the accurus vitrectomy probe lots impacted by this issue. regular post-operative patient follow-up may enable the surgeon to detect early potential abnormal inflammatory reaction and/or infection, which may reduce the severity of the ensuing event.

Customers are advised to immediately stop further use of the affected lots and to segregate them to ensure that they are not used. Alcon will provide reimbursement for all returned product This action has been closed-out on 9/08/2016.