Class 2 Device Recall Rayner RayOne EVM RAO200E (19.0 Diopter and 21.0 Diopter) intraocular lens (IOL)

• Date Initiated by Firm: May 13, 2022
• Create Date: July 06, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1338-2022
• Recall Event ID: 90301
• PMA Number: P060011S025
• Product Classification: intraocular lens - Product Code HQL
• Product: RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens:; ; (1) Outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph: +19.00D; and ; (2) Inner primary device packaging labeled as Rayner RayOne EMV US, REF RAO200E, SE: +21.00D, Sph: +21.00D.
• Code Information: Outer carton +19.0 D - Batch #012183745, exp. 1/17/2024, Serial numbers 01-06, 10, 21, 24-45, 48-53, 58-60, 61-65, and 68-81, UDI (01)05029867006685. Outer carton +21.0 D - Batch #012183845, exp. 1/17/2024, all serial numbers, UDI (01)05029867006722.
• Recalling Firm/ Manufacturer: Rayner Intraocular Lenses Ltd; 10 Dominion Way; Worthing United Kingdom
• Manufacturer Reason for Recall: The outer package is mislabeled and the package contains a different IOL strength.
• FDA Determined Cause: Under Investigation by firm
• Action: The recalling firm sent two emails to the importer warehouse on 5/12/2022 instructing them to freeze all units of the affected lots from further distribution, provide the number of units in inventory, and to provide the accounts who have been sent the units so they can track them. On 5/13/2022, the recalling firm sent an email to their sales team requesting all unused units from the affected batch be returned to a designated warehouse (the importer, which was listed as a direct account). The email included an attached letter and a response form that the sales team was to send to any of their accounts who are affected. The email noted that Rayner would cover all return costs and replace the affected stock. The attached customer letter was dated 5/13/2022 requesting return of all unused units of the affected batch to the address listed in the letter. The letter noted that an official letter will follow subject to FDA approval, however, in the interim, the customer was requested to complete and returned the attached response form. The response form was to be completed with the lot number of the IOL, whether it was implanted, the date implanted, was there a refractive error, whether it is being returned, and the date of return. The facility is to indicate they have read and understood the contents of the letter and that all affected persons have been notified of the field action. A second letter was issued to the customers dated 5/24/2022 via email on the same date. The customer was requested to complete and return the attached response form at their earliest convenience if not already done. The email also asked for additional information be provided if the IOL has been implanted, such as (1) confirm the patient's post-operative outcome; (2) if applicable, confirm the degree of the refractive error; (3) does the refractive error require correction; and (4) if the refractive error requires correction, is surgical exchange expected. The attached letter expla
• Quantity in Commerce: 162 IOLs
• Distribution: US Nationwide distribution in the states of AZ, CA, FL, GA, IN, MI, MN, MO, ND, NJ, OK, TN, and TX.
• 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.

• PMA Database: PMAs with Product Code = HQL and Original Applicant = RAYNER INTRAOCULAR LENSES LTD.