Skip to content

ACRYSOF® IQ RESTOR® SN6AD1 (UDI 00380652241182)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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652241182), received between Jul 8, 2022 and Jul 8, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Opacification” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Opacification1

Patient problems

  • Visual Impairment1

Recent adverse event reports

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

  • MalfunctionJul 8, 2022Material Opacification; Material Opacification

    A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS SEEMS TO BE CLOUDED AND THE VISUAL ACUITY DECREASED TO 0.3. CURRENTLY THERE IS NO LENS EXCHANGE PLANNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Visual Impairment

    MAUDE report 14953445 ↗

Other LENS, MULTIFOCAL INTRAOCULAR devices

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.