Class 2 Device Recall Acrysof.IQ IOL w/UltraSert, System

• Date Initiated by Firm: April 17, 2020
• Create Date: June 05, 2020
• Recall Status: Terminated on February 05, 2021
• Recall Number: Z-2287-2020
• Recall Event ID: 85563
• PMA Number: P930014S084
• Product Classification: intraocular lens - Product Code HQL
• Product: Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.
• Code Information: Lot number 12726594; Model Number: AU00T0V205; UDI # 038065GMN000065H7; 0380652394772(17)220630(21)12726594000(30)1
• FEI Number: 1610287
• Recalling Firm/ Manufacturer: Alcon Research LLC; Aspex Facility; 6201 South Fwy; Fort Worth TX 76134-2099
• For Additional Information Contact: Heather Attra; 817-293-0450
• Manufacturer Reason for Recall: Incorrect IOL diopter
• FDA Determined Cause: Process control
• Action: On 04/17/2020, the firm sent an "Urgent: Voluntary Medical Device Removal' letter to customers via overnight mail that the firm became aware that there was a potential problem relating to the IOL of wrong sized diopter, in a pre-loaded delivery system. Should a patient be implanted with an IOL having incorrect optical power, a refractive error would result. Patients with a refractive error may experience symptoms from mild blurred vision to decreased vision, which may require additional interventions such as spectacles or surgical intervention to correct. The firm is instructing customers to: (i) Return any unused product of specified lot number (ii) The firm's Customer Service will contact customers to arrange for the return and replacement of affected Pre-loaded delivery system (iii) Fill out "Response Form" (iv) Return the "Response form" via fax or email to the firm, provided of contact information: Fax No.: 817-302-4337; E-mail: Market.Actions@alcon.com Additionally, the firm is asking customers to: Reach out to firm's Sales Representative for any questions.
• Quantity in Commerce: 84 units
• Distribution: US Nationwide distribution including in the states of TX, PA, CT, IA, MI, NE.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = HQL