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:
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 7 August 2018