Class 2 Device Recall Phoroptor VRx Digital Refraction System

• Date Initiated by Firm: July 20, 2023
• Date Posted: August 31, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2512-2023
• Recall Event ID: 92805
• Product Classification: Refractor, manual, non-powered, including phoropter - Product Code HKN
• Product: PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye. ; MODEL NUMBER: 16242
• Code Information: GTIN: 0812559011730 S/N: 78824-1221 78825-1221 78826-1221 78827-1221 78828-1221 78829-1221 78830-1221 78831-1221 78832-1221 78833-1221 78834-1221 78835-1221 78836-1221 78837-1221 78838-1221 78839-1221 78840-1221 78841-1221 78842-1221 78843-1221 78844-1221 78845-1221 78846-1221 78847-1221 78848-1221 78849-1221 78850-1221 78851-1221 78852-1221 78853-0122 78854-0122 78855-0122 78856-0122 78857-0122 78858-0122 78859-0122 78860-0122 78861-0122 78862-0122 78863-0122 78864-0122 78865-0122 78866-0122 78867-0122 78868-0122 78870-0122 78871-0122 78872-0122 78873-0122 78874-0122
• Recalling Firm/ Manufacturer: Reichert, Inc.; 3362 Walden Ave; Depew NY 14043-2437
• For Additional Information Contact: SAME; 716-686-4500
• Manufacturer Reason for Recall: Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthalmic stand. If the Phoroptor VRx Head detaches from the bracket, it can fall onto a patient or device operator
• FDA Determined Cause: Device Design
• Action: Reichert contacted authorized distributors and direct accounts who were shipped devices within the scope of the campaign on, July 20, 2023. The letter informed them of the product correction and the need to provide Reichert with the end-user location and contact information for all affected units. The Customer Urgent Medical Device Correction - Prompt Attention Required Letter issued July 27, 2023. Letter states reason for recall, health risk and action to take: While Reichert plans a thorough inspection of all units manufactured between December 2021 and January 2022, pending completion of the Reichert visit to your location, please conduct the abbreviated inspection shown in the image below. If a unit displays the condition described, please remove it from service immediately. Please contact our Reichert Technical Support Team at 1-888-849-8955 immediately to schedule an appointment with the Reichert Service Team. A Reichert Service Team Member will visit your location, inspect your unit(s), and make any necessary repairs If your unit displays the defect condition described above, we will prioritize your site inspection. Reichert will inspect and repair all units in the relevant manufacturing range. Please schedule an appointment with Reichert even if your unit does not display the defect condition described above. It is necessary that ALL units be inspected by Reichert. If you prefer, you may send your unit to Reichert for inspection and repair. The Reichert Technical Support Team can provide you with a Return Merchandise Authorization. Inspections and repairs will be completed at no cost to you.
• Quantity in Commerce: 50 units
• Distribution: US Nationwide distribution.
• 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.