AcrySof® IQ ReSTOR® SV25T3 (REF SV25T3U225)Recalls & reported problems

Alcon Laboratories, Inc. · AcrySof® IQ ReSTOR® MultiFocal Toric IOL, UV w/ Blue Light Filter, PC Lens, 13.0mm Length, 6.0mm Biconvex Optic, Planar Haptics · Class 3 · Implant

All models of ACRYSOF IQ RESTOR (34)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652311267), received between Jul 6, 2022 and Jul 6, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Device Dislodged or Dislocated1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionJul 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
A CUSTOMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS HAS BEEN DISPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14929445 ↗

Device details

UDI-DI	`00380652311267`
Brand	AcrySof® IQ ReSTOR®
Model	SV25T3
Catalog no.	SV25T3U225
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

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All LENS, MULTIFOCAL INTRAOCULAR devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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