Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Alcon Laboratories Alcon Phaco Tips and packs or kits containing [Multiple catalogue numbers; Multiple product codes] [HKMD no.: 080059, 080150, 090145, 170334].
According to TGA, the manufacturer has become aware that in instances where the Phaco Tip is over-tightened with the included plastic wrench, to the point where the wrench slips over the tip-to-wrench interface, there is a potential for plastic particles to be shaved from the interior of the included plastic wrench. This potential for generation of particles is not present in cases where the Phaco Tip is not over-tightened. If particles are generated from the plastic wrench by overtightening the Phaco Tip and subsequently enter the patient’s eye during surgery, there is a potential risk of intra- and/or post-operative complications, including intraocular tissue damage, bleeding, and/or associated inflammation.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00616-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 Jul 2023