ACRYSOF® IQ RESTOR® SN6AD1 (UDI 00380652241076)Recalls & reported problems

Alcon Laboratories, Inc. · AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC. · Class 3 · Implant

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652241076), received between Aug 29, 2024 and Aug 29, 2024 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Posterior Capsule Opacification1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL VIA A REGULATORY AGENCY REPORTED THAT A PATIENT HAD BILATERAL IMPLANTATION OF INTRAOCULAR LENS. IN JUNE 2016, DUE TO OPACIFICATION, THE PATIENT HAD TO UNDERGO VITRECTOMY AND YAG LASER TREATMENT. SINCE THE PREVIOUS AUGUST, CLOUDINESS HAD REOCCURRED IN THE PATIENT¿S EYES AND HAD BEEN WORSENING. THE PATIENT¿S OPTOMETRIST DIAGNOSED THE EARLY DEVELOPMENT OF CATARACTS. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Posterior Capsule Opacification
MAUDE report 20096146 ↗

Device details

UDI-DI	`00380652241076`
Brand	ACRYSOF® IQ RESTOR®
Model	SN6AD1
Company	Alcon Laboratories, Inc.
Product code	MFK · LENS, MULTIFOCAL INTRAOCULAR
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jul 8, 2021

Device type (GMDN): Posterior-chamber intraocular lens, pseudophakic

An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.