Events

Safety Alert for Algerbrush- II and its accessories

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Bausch & Lomb.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-11-28
  • Event Date Posted
    2016-11-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161128.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: bausch & lomb algerbrush- ii and its accessories 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internal investigation by the manufacturer found that the operating instructions packed with the product are missing or out of date.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.

Device

Algerbrush- II and its accessories
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Algerbrush- II and its accessories
  • Manufacturer
    Bausch & Lomb

Manufacturer

Bausch & Lomb