Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/...

FDA Device Recall #Z-2287-2020 — Class II — April 17, 2020

Recall Summary

Recall Number Z-2287-2020
Classification Class II — Moderate risk
Date Initiated April 17, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Alcon Research LLC
Location Fort Worth, TX
Product Type Devices
Quantity 84 units

Product Description

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.

Reason for Recall

Incorrect IOL diopter

Distribution Pattern

US Nationwide distribution including in the states of TX, PA, CT, IA, MI, NE.

Lot / Code Information

Lot number 12726594; Model Number: AU00T0V205; UDI # 038065GMN000065H7; 0380652394772(17)220630(21)12726594000(30)1

Other Recalls from Alcon Research LLC

Recall # Classification Product Date
Z-0939-2026 Class I Brand Name: Alcon Laboratories, Inc. Product N... Nov 24, 2025
Z-0326-2026 Class II Alcon PRECISION1 One-Day Contact Lenses, -2.25D. Sep 30, 2025
Z-0581-2026 Class II CONSTELLATION ULTRAVIT 10K and CONSTELLATION HY... Sep 15, 2025
Z-0305-2026 Class II Brand Name: Alcon Laboratories, Inc. Product N... Aug 5, 2025
Z-0308-2026 Class II Brand Name: Alcon Laboratories, Inc. Product N... Aug 5, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.