ACRYSOF® RESTOR® SV25T0 (UDI 00380652307734)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 00380652307734), received between Sep 15, 2022 and Sep 15, 2022 — 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.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Blurred Vision1
Corneal Edema1
Visual Impairment1

Recent adverse event reports

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

InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CERTIFIED OPHTHALMIC ASSISTANT (HEALTH CARE PROFESSIONAL) FOLLOWING IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT EXPERIENCED DECREASED VISION (UNHAPPY WITH VISION) AND DIPLOPIA (DOUBLE VISION). POST SURGERY, THE PATIENT EXPERIENCED CORNEAL EDEMA AND VISION HAS BEEN GETTING WORSE OVER TIME. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH NON COMPANY IOL. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Corneal Edema; Visual Impairment
MAUDE report 15427480 ↗

Device details

UDI-DI	`00380652307734`
Brand	ACRYSOF® RESTOR®
Model	SV25T0
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	Mar 26, 2024

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.

Other LENS, MULTIFOCAL INTRAOCULAR devices

Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
144 reports
Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
1 recall66 reports
Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
113 reports
Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
112 reports
Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
110 reports
Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
107 reports
Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
104 reports
Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
93 reports

All LENS, MULTIFOCAL INTRAOCULAR devices →

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