Skip to content

ACRYSOF® RESTOR® SV25T0 (UDI 00380652307796)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

All models of ACRYSOF RESTOR (14)

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

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652307796), received between Sep 28, 2022 and Oct 10, 2022 — classified as 3 injuries.

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

  • Adverse Event Without Identified Device or Use Problem3

Patient problems

  • Visual Impairment3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR UNCORRECTED AND BEST CORRECTED VISION AND THERE WAS NO IMPROVEMENT WITH THE LUBRICATION THERAPY. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATED THAT PATIENT UNDERWENT INTRA OCULAR LENS (IOL) EXCHANGE FOR MONOFOCAL IOL IN THE RIGHT EYE. ONE DAY AFTER SURGERY THE NEW IOL APPEARED CENTERED AND STABLE. NO FURTHER INFORMATION AVAILABLE.

    Patient problems: Visual Impairment

    MAUDE report 15569160 ↗
  • InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AN HEALTHCARE PROFESSIONAL REPORTED THAT IN A STUDY, AFTER INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE STUDY PATIENT EXPERIENCED AN INABILITY TO SEE WELL POSTOPERATIVELY WITH THE LENSES. THE IOLS WERE REMOVED DURING THE SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS NOT REQUESTED DUE TO LACK OF REPORTER CONTACT INFORMATION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR 1ST EYE.

    Patient problems: Visual Impairment

    MAUDE report 15500909 ↗
  • InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AN HEALTHCARE PROFESSIONAL REPORTED THAT IN A STUDY, AFTER INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE STUDY PATIENT EXPERIENCED AN INABILITY TO SEE WELL POSTOPERATIVELY WITH THE LENSES. THE IOLS WERE REMOVED DURING THE SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS NOT REQUESTED DUE TO LACK OF REPORTER CONTACT INFORMATION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR 2ND EYE.

    Patient problems: Visual Impairment

    MAUDE report 15500713 ↗

Other LENS, MULTIFOCAL INTRAOCULAR devices

All LENS, MULTIFOCAL INTRAOCULAR devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page