Starting from 1 January 2022, safety alerts related to medical devices listed under MDACS that have potential serious health risk/ public health risk to local population are listed below.
Medical device manufacturer, CooperVision, has notified Department of Health about a safety issue concerning Biofinity [Sphere Power: -07.00; Lot number: 12908050243028, 12908050279028] [HKMD No.: 090389].
The manufacturer received a single technical customer complaint for a floating particle in a Biofinity Sphere blister in Korean market which was processed between the 18th and 21st January 2020. The particle was identified as a fragment of a polymer based (non-ferrous) cleaning pad floating in the packaging solution in the blister. According to the manufacturer, the most likely effect is that if the lens were worn and fragments were on the lens, then some minor irritation would occur, which could be mitigated by lens removal and replacement.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your vendor / local supplier for necessary actions. The local supplier has also provided an alternative contact InfoHK@coopervision.com to answer customer inquiries.
Posted on 17 May 2023