Recall Z-0614-2021

Reason for recall

Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guaranteed in that the safety function of the board would be insufficient resulting in an increased leakage of current and potentially cause electrical shocks to the user.

FDA-determined cause: Nonconforming Material/Component

Action taken

On 08/18/2020, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via FedEx overnight informing customers that based on post market surveillance activities, the Recalling Firm found that the communication board on their digital lensmeter and autorefractor were not performing as expected and needs to be exchanged as a precautionary measure. In rare cases the RS232 communication port can fail on the communication board. Both products use the same technology. 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 the communication board fails without connecting a third-party device, a burning smell can occur as a result of a thermal event. Customers are to note that the outer housing materials of the lensmeter and autorefractor fulfill the normative requirement concerning flammability. Actions to be taken by the Customer/User: The Recalling Firm is asking customers to disconnect all non-medical grade devices from the affected device RS232 interfaces. If the affected devices are connected to a digital phoropter a disconnection is not needed. Furthermore, the Recalling Firm is asking customers to switch off the affected devices when customers cannot supervise the device, especially when they close their location after working hours. Customers will receive additional information about the handling of this recall from their local service organization. The Recalling Firm is planning to replace the affected component at the next available opportunity. For questions regarding this Recall, contact Customer Support at 877-486-7473.