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ACRYSOF® IQ RESTOR® SN6AD1 (UDI 00380652249591)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 00380652249591), received between Dec 3, 2021 and Dec 3, 2021 — 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

  • Blurred Vision1

Recent adverse event reports

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

  • MalfunctionDec 3, 2021Material Opacification; Material Opacification

    A PHARMACIST REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED LOW VISION. THE POSTERIOR CHAMBER OF THE LENS WAS OPACIFIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Blurred Vision

    MAUDE report 12926318 ↗

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.