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ACRYSOF® IQ RESTOR® SN6AD3Recalls & reported problems

Alcon Laboratories, Inc. · AcrySof(R) ReSTOR(R) APODIZED DIFFRACTIVEASPHERIC SINGLE-PIECE IOL, 13.0mm LENGTH,6.0mm 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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380655101148), received between Sep 17, 2024 and Sep 17, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
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

  • Blurred Vision1
  • 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 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A CONSUMER WHO HAD UNDERGONE INTRAOCULAR LENS (IOL) IMPLANTATION ON 01/16/2008 IN RIGHT EYE, REPORTED THAT HE HAD BEEN EXPERIENCING BLURRED VISION IN RIGHT EYE FOR LAST TWO MONTHS. HE STATED THAT HE HAD SEEN HIS OPHTHALMOLOGIST WHO DID NOT PROVIDE ANY REASON FOR THE BLURRED VISION, BUT TOLD IT WAS TOO RISKY TO REMOVE THE LENS. HE HAD UNDERGONE LASIK PROCEDURE AND YAG (YTTRIUM-ALUMINUM-GARNET LASER) ON (B)(6) 2018. ACCORDING TO THE PATIENT RECORD FROM (B)(6) 2018, ALMOST THREE MONTHS AFTER YAG, HE STATED THAT HE WAS NOT REALLY NOTICING ANY IMPROVEMENT AND WAS STILL SEEING FILM OVER HIS RIGHT EYE. HIS VISION WAS BLURRY AND FUZZY. ACCORDING TO THE PATIENT RECORD FROM (B)(6) 2021, HIS DISTANCE VISION WAS GETTING FOGGY, BUT NEAR VISUAL ACUITY WAS GOOD.

    Patient problems: Blurred Vision; Visual Impairment

    MAUDE report 20238481 ↗

Other LENS, MULTIFOCAL INTRAOCULAR devices

All LENS, MULTIFOCAL INTRAOCULAR devices →

Sources and updates

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