Class 2 Device Recall Phoroptor VRx

• Date Initiated by Firm: February 28, 2025
• Date Posted: March 31, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1500-2025
• Recall Event ID: 96266
• Product Classification: Refractor, manual, non-powered, including phoropter - Product Code HKN
• Product: Phoroptor VRx Digital Refraction System Model Numbers: 16241
• Code Information: Model Numbers: (1) 16241; UDI-DI: (1) 00812559011716; Serial Numbers: TBD; Note: The majority of units within the scope of the planned recall are older devices which do not have a UDI on the label.
• FEI Number: 1000159913
• Recalling Firm/ Manufacturer: Reichert, Inc.; 3362 Walden Ave; Depew NY 14043-2437
• For Additional Information Contact: Richard Boerdner; 716-686-4556
• Manufacturer Reason for Recall: The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
• FDA Determined Cause: Process control
• Action: On February 28, 2025 "URGENT MEDICAL DEVICE RECALL" letters were sent to customers. PLEASE TAKE THE FOLLOWING ACTIONS IMMEDIATELY. 1. Inspect your Phoroptor head with reference to Figure 1 for looseness or rocking and Figure 2 for an excessive gap between components. Figure 3 shows the normal condition. 2. If your unit exhibits looseness or rocking or if there is an excessive gap between components, it is possible that your unit has the defect condition. Please remove it from service immediately and contact Reichert Technical Support at 1-888-849-8955 or at https://www.reichert.com/en/support/rma-request so that the unit can be inspected and, if necessary, repaired by Reichert. The repair will be completed at no cost to you. 3. If your unit shows the normal condition as in Figure 3, please install the Support Bracket when you receive it. It is essential that you install the Support Bracket for the safety of patients and operators even if the components appear tight and securely connected. Without the bracket, there could be eventual separation of the components. The Support Bracket prevents this possibility. The internal investigation into this issue has indicated the need for these corrections and resulted in a plan that includes actions designed to prevent a recurrence of this situation. Reichert prides itself on the quality of devices we manufacture. Please share this letter with all the relevant personnel in your organization. Please contact Reichert Technical Support with any questions. They can be reached Monday through Friday, 8:00AM to 5:00PM Eastern Time at 1-888-849-8955 or at https://www.reichert.com/en/support/support-and-service-inquiry.
• Quantity in Commerce: 122 units
• Distribution: Domestic: Nationwide Distribution. International: Austria, Bolivia, Canada, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Morocco, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, Slovakia, Switzerland, Thailand, United Arab Emirates, and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.