Medical device manufacturer, Carl Zeiss, has issued a medical device safety alert concerning its VISULENS 550 digital lensmeter.
Based on the manufacturer's post market surveillance activities, it was found that the communication board is not performing as expected and need to be exchanged as a precaution measure. In rare cases the RS232 communication port can fail on the communication board.
According to the manufacturer, the effectiveness of the communication board cannot be guaranteed. In the worst-case situation, the safety function of the communication board is insufficient when a connected third-party device is causing an electrical overload at the RS232 interface. This could result in an increased leakage current and electrical shock for the user/patient. If there is no device connected to the RS232 interface, there is no risk for an electrical shock. If the communication board fails without connecting a third-party device, in rare cases a burning smell can occur as a result from a thermal event. The outer housing materials of the VISULENS 550 fulfill the normative requirement concerning flammability.
The manufacturer is instructing affected users to disconnect all non-medical grade devices from the VISULENS 550 interface. If the VISULENS 550 is connected to a VISUPHOR 500 digital phoropter, a disconnection is not needed. The manufacturer recommends affected users to switch off the VISULENS 550 when they cannot supervise the device, especially when they close their location after the working hours.
The manufacturer is planning to replace the affected component at the next opportunity. The repair of affected unit is mandatory.
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 10 August 2020