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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00481-1
Product Name/Description ACCURUS Vitrectomy probes

ACCURUS 23GA Standalone Vitreous Probe
Catalog # 8065750821
Lot number: 14017912X

Anterior ACCURUS® Probe with infusion needle
Catalog # 8065803650
Lot numbers: 14010430X, 140174S1X, 14010430X, 14017451X

ARTG Numbers 140947 and 145666
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 5/06/2015
Responsible Entity Alcon Laboratories Australia Pty Ltd
Reason/Issue 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.
Recall Action Recall
Recall Action Instructions 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.
Contact Information 02 9452 9387 Alcon