Events

Safety Alert for Stellaris Elite Single Port Vitrectomy Cutters

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
    2018-08-07
  • Event Date Posted
    2018-08-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180807.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 stellaris elite single port vitrectomy cutters medical device manufacturer, bausch & lomb, has issued a medical device safety alert concerning its stellaris elite single port vitrectomy. the manufacturer is conducting a voluntary recall of 29 lots of the affected products in gauge sizes 20, 23 and 25 after receiving a limited number of customer reports of the back cap separating from the body of the cutter during surgery. no reports of patient injury have been reported as a result of these incident. according to the manufacturer, the vitrectomy cutter handle is assembled by press-fitting the back cap to the vitrectomy cutter body. bonding agent is then applied to the handle seam where it wicks into the assembly interface. during operation the seal joint can be exposed to a maximum internal pulse pressure of 42 psi. probable cause for the failure has been identified as insufficient bonding agent between vitrectomy cutter back cap and body. quality change request was initiated to further investigate and improvements to the bonding process have been implemented during production. product replacement is on-going. according to the local supplier, the affected products has been imported in hong kong. the impacted lots, however, are not released to market and are held in its warehouse. they are identified as below: 20ga 7.5k pneumatic vit cutter [part number: bl5626; lot number: v9400] 23g post elite w mf 6/bx [part number: se5423mv; lot number: w1721, w0147] 23g post elite w wf 6/bx [part number: se5423wv; lot number: w0148] 25g post elite w wf 6/bx [ part number: se5425wv; lot number: w0157] 23g combo elite w mf 6/bx [part number: se5523mv; lot number: w0783] 25g combo elite w mf 6/bx [part number: se5525mv; lot number: w0787] if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 august 2018.

Device

Stellaris Elite Single Port Vitrectomy Cutters
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Rupture of Membranes Tests
  • Manufacturer
    Bausch & Lomb

Manufacturer

Bausch & Lomb