Medical device manufacturer, Bausch & Lomb, has issued a medical device safety alert concerning Algerbrush- II and its accessories [Product description (Part number): 1) Algerbrush-II 0.5mm (E0815 A) ; 2) Algerbrush-II 1.0mm (E0815 B); 3) Burr/Chuck Replaces 0.5mm (E0815 0.5); 4) Burr/Chuck Replaces 1.0mm (E0815 1.0); 5) Pterygium Burr Medium Diamond (E0816 C)].
An internal investigation by the manufacturer found that the operating instructions packed with the product are missing or out of date.
The manufacturer advises users that the Algerbrush-II can continue to be used following the updated sterilization instructions provided in the field safety notice. The new operating instructions now contain specific time and temperature for sterilization. Failure to follow the new revised operating instruction can result in potential adverse events including eye infections.
The manufacturer will send the updated operating instruction (Rev.3 April 2012) to all affected customers.
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 supplier for necessary actions.
Posted on 28 November 2016