ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ...

FDA Device Recall #Z-2323-2015 — Class I — April 15, 2015

Recall Summary

Recall Number Z-2323-2015
Classification Class I — Serious risk
Date Initiated April 15, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Alcon Research, Ltd.
Location Fort Worth, TX
Product Type Devices
Quantity 45,391

Product Description

ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan.

Reason for Recall

There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.

Distribution Pattern

Distribution Japan, No US distribution.

Lot / Code Information

Model Numbers: SN6AD1, SN6AD3, SV25T0, MN6AD1,SND1T3, SND1T4, SND1T5 and SND1T6 and all lot numbers.

Other Recalls from Alcon Research, Ltd.

Recall # Classification Product Date
Z-2408-2023 Class II Infinity FMS Pak Jun 28, 2023
Z-2407-2023 Class II Centurion FMS Pak Jun 28, 2023
Z-2406-2023 Class II Constellation Procedure Pak Jun 28, 2023
Z-2410-2023 Class II Phaco Standalone Tips Jun 28, 2023
Z-2411-2023 Class II Alcon Custom Pak Jun 28, 2023

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.